2016 Catalogue 2017

Food & Water Assays PCR Cycler Validation

Contract Nucleic Acid Manufacturing Extraction

Cell Culture Contamination DNA Standards & Control Cleaning Products Introduction

Facts Minerva Biolabs, founded in 1999, is a privately owned company. Our office and manufacturing fa- cilities are located in Berlin, Germany. The company is part of the Dilarus Group, a privately owned holding company, that is providing product design and communication services to the group mem- bers. Further group members are the Mera Scientific GmbH, a distributor of internationally avaliable molecular diagnostic technologies to the German market, and the Minerva Analytix GmbH, a GMP- certified QC lab for biopharmaceutical and ATMP release testing.

Our Assets We serve our customers with our dedicated and well-trained distribution partners in more than 50 countries across the five continents.

We lead in the niche markets with solutions for EP 2.6.7-compliant mycoplasma contamination test- ing, meat identification testing, vegan food control, PCR cycler qualification, and validation standards to give just a selection of our innovative product portfolio. All these products feature the latest PCR technology.

We bring high-value solutions to our customers through our expertise and longstanding experience reflected in our products and contract manufacturing services. If you are looking for an expert and flexible partner for the preparation of your molecular biology kit or reagent, Minerva Biolabs is the right choice. Automated liquid-handling, freeze-drying technology and clean room facilities are avail- able to comply with any customer demand.

We serve academic and industrial cell culture laboratories, quality control units in biopharmaceutical industry as well as food quality professionals providing a service for faster, reliable and stress-free technologies for their specific needs.

We do not stop with single applications like PCR but aim to provide integrated solutions that are required for handling cell cultures contamination-free with our elimination and disinfection reagents, or for operating PCR labs contamination-free with our DNA and RNA removal reagents as well as monitoring tools.

We bring experiences and services to markets that are undersupplied by the major industry players that provide mainly products without support. Customized guidance is our strength as we develop products and apply them routinely in our labs. Based on our experiences, we seek to further improve our products and develop new products to offer innovative solutions to our customer, which keeps Minerva Biolabs on a constant path of growth.

We are highly committed to quality and implemented a quality management system that was certi- fied according to ISO 9001 in the first business year. Since 2007, we conduct our business according to ISO 13485 which enables us to manufacture IVDs according to the in-vitro diagnostic directive. Many customer and authority audits proved the conformity of our quality management system.

2 3 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Bestellinformationen Ordering Information

Wir nehmen Ihre Bestellungen gerne über unseren Wieviel kostet der Versand? All customers may order via our online shop, by e- Free shipping for qualified orders Onlineshop, per E-Mail, per Fax oder telefonisch ent- Wir berechnen in Deutschland für alle Versendun- mail, fax, or telephone. For customers outside of Within Germany, shipping charges are 10.50 Euro gegen. Ausländische Kunden können sich direkt an gen regulär 10,50 Euro. Alle Bestellungen mit einem Germany, please contact the Minerva Biolabs’ dis- for standard shipment. Minerva Biolabs will pay the unsere Vertriebspartner wenden. Diese stellen auch Bestellwert von mehr als 300 Euro sind versandkos- tributor within your country. If your country does not shipping charges for any order within Germany that Preisinformationen zur Verfügung. tenfrei. Für Bestellungen aus dem Ausland fallen die have an authorized distributor, our online shop will totals 300 Euro or more. Please inquire about costs effektiven Versandkosten an. guide you. for international shipments at info@minerva-biolabs. Telefon: +49 (0)30 2000437-0 com. Fax: +49 (0)30 2000437-9 Wann wird die Ware geliefert? Telefon: +49 (0)30 2000437-0 Web: www.minerva-biolabs.com Wir liefern Bestellungen bis 12.00 Uhr noch am sel- Fax: +49 (0)30 2000437-9 Same day shipping E-Mail: [email protected] ben Tag aus. Die Ware trifft innerhalb von 1-3 Werkta- Web: www.minerva-biolabs.com Orders will be shipped the same day until 12 AM, un- Shop: http://shop.minerva-biolabs.com gen bei Ihnen ein. Weniger robuste Produkte, wie z.B. E-mail: [email protected] less otherwise stated or requested. Non-perishables die Polymerasen, werden normalerweise nicht am Shop: http://shop.minerva-biolabs.com can be shipped from Monday to Friday. To assure pro- Informationen, die Sie für eine Bestellung benö- Freitag versendet, um ihre Integrität zu garantieren. duct integrity, less robust products like polymerases tigen Bitte kontaktieren Sie Minerva Biolabs für besonde- Information to provide with your order normally are not shipped on Friday. However, please 1 Ihren Namen, Telefonnummer re Vereinbarungen. 1 Name, telephone number, and e-mail contact Minerva Biolabs for special arrangements. und E-Mail- Adresse Bei Lieferverzögerungen werden Sie natürlich umge- address In case of a delay in delivery we will inform you im- 2 Institut/Firma hend benachrichtigt. Auf Anfrage senden wir Ihnen 2 Company/institute mediately. If requested we will send you the confir- 3 Liefer- und ggf. Rechnungsadresse unverzüglich eine Auftragsbestätigung zu. Wir behal- 3 Shipping and billing address mation of your order without delay. 4 ggf. Ihre Auftragsnummer ten uns vor, Produktspezifikationen und Preise ohne 4 Purchase order number Prices are subject to change without notice. Please con- 5 Bestellnummer Vorankündigung zu ändern. Preise und Spezifikatio- 5 Catalog number firm current pricing at the time of your order. 6 Produktname, Packungsgröße und Menge nen bestätigen wir gerne auf Anfrage. 6 Product name, size, and quantity For more detailed information, Zahlungsbedingungen Weitere Fragen beantworten wir Ihnen gerne und Terms of payment please contact: Zahlungsziel ist 14 Tage nach Rechnungserhalt ohne schnell unter: Terms of payment is 14 days after receipt of invoice. E-mail: [email protected] Abzug. Die Ware bleibt bis zur vollständigen Bezah- E-Mail: [email protected] The goods remain our property until payment of the Phone: +49 (0)30 2000 4370 lung unser Eigentum. Es gelten die Allgemeinen Ge- Telefon: +49 (0)30 2000 4370 invoice. The terms and conditions apply. schäftsbedingungen. Official mailing address Postanschrift Our VAT No. Minerva Biolabs GmbH Unsere Umsatzsteuernummer Minerva Biolabs GmbH DE199467805 Koepenicker Strasse 325 DE199467805 Köpenicker Straße 325 12555 Berlin D-12555 Berlin Germany

Technische Anfragen Technical Support

Für viele unserer Produkte bieten wir ergänzende In- mit einer individuellen und kompetenten Betreu- For many of our products, we are able to provide ad- petent support. Please use for your inquiry our form formationen auf unserer Webseite an. Bitte rufen Sie ung zur Verfügung und unterstützen Sie gerne bei ditional information on our website. Please access on the website http://www.minerva-biolabs.com/en/ die jeweilige Produktseite auf und achten Sie auf die Schwierigkeiten jeglicher Art. Bitte verwenden Sie für the respective product page and have a look at the contact. Einträge an der rechten Seite. Ihre Anfrage unser Formular auf der Webseite http:// links on the right side. If this information does not Sollten diese Informationen Ihnen nicht weiter- www.minerva-biolabs.com/de/kontakt. help you, please contact our support team. They helfen, stehen wir unseren Kunden natürlich gerne are glad to assist you with an individual and com-

4 5 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Cell Culture Contamination Control 8 Meat ID™ Kits 54 ExtractNow™ Meat ID 55 Introduction 10 Meat ID™ Screen 56 Meat ID™ Halal 57 Mycoplasma Detection Kits 12 Venor®GeM Classic 13 Vegan Control™ Kits 58 Venor®GeM Advance 14 ExtractNow™ Vegan Control 59 Venor®GeM OneStep 15 Vegan Control™ OneStep 60 Venor®GeM qEP 16 Vegan Control™ Advance 61 Venor®GeM Sample Preparation Kit 17 10CFU™ ​Mycoplasma Sensitivity Standards 18 Nucleic Acid Extraction 62 Mycoplasma Elimination Reagents 20 ExtractNow™ Plasmid Mini Kit 64 Mynox® 22 ExtractNow™ DNA Mini Kit 65 Mynox® Gold 23 ExtractNow™ Blood DNA Mini Kit 66 ExtractNow™ RNA Mini Kit 67 Onar® – Bacteria Detection Kit 24 ExtractNow™ CleanUp Kit 68 Decontamination, Disinfection, and Prevention 26 ExtractNow™ Virus DNA/RNA Kit 69 ZellShield® 27 Mycoplasma-Off™ 28 DNA Standards and Cleaning 70 Mycoplasma-Off™ Wipes 29 WaterShield™ 30 DNA Standards 72 MB Taq DNA Polymerase 31 Specifity Standards 72 Genomic DNA Extracts 72 PCR Cycler Validation 32 PCR Quantification Standards 74 10CFU™ 76 Introduction 34 Cleaning 78 PCR Cycler Check™ 35 PCR Clean™ Spray 79 qPCR Cycler Check™ 36 PCR Clean™ Wipes 80 Color Compensation Kit 37 Lab Clean™ 81 WaterShield™ 82 Food and Water Testing 38 AquaScreen® 40 Contract Manufacturing 84 AquaScreen® FastExtract 42 AquaScreen® species 43 Appendix 88 AquaScreen® 44 AquaScreen® 45 Licenses & Trademark Information 88 AquaScreen® 46 Terms and Conditions 89 Food Control™ 48 ExtractNow™ FoodControl 50 Index 92 Food Control™ qPCR 51 Food Control™ LFA 52 Food Control™ LFA+ 53

6 7 Cell Culture Contamination Control

8 9 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Introduction

M. salivarium 5% M. hyorhinis 20%

M. orale 23%

Other 18% M. fermentans 3%

M. hominis 5%

A. laidlawii 9% M. arginini 17%

Incidence Solution Besides contamination with yeast, fungi and other cell types, the contamination of cell cultures with The PCR method can easily fulfil the requirements of a modern test system on specificity and robust- viruses, bacteria and mycoplasma is widely spread. Up to 87 % of all cell cultures in academic use and ness. The sensitivity of the test method is limited by the low sample volume. To fulfil the sensitivity li- up to 4 % in industrial production are contaminated with mycoplasma. Approx. 6 % of all autologous mits based on the culture method (CFU/ml), concentration methods or cell culture enrichment might cells used for therapeutic purposes are contaminated with undetected bacteria. The regular use of an- apply, the later even solving the problem of direct testing methods with DNA from dead mycoplasma. tibiotics in cell culture media suppresses the bacterial growth to a level which is undetectable without Spiking a cell culture with 10 vital mycoplasma particles gives a strong detectable PCR signal within a suitable detection method. one week of cultivation; DNA from dead mycoplasma will be digested by DNA nucleases of lysed cells within days of cultivation. Impact It is important to keep an eye on these contaminants during routine work for diverse and severe rea- Regulated Testing sons: inhibition of cell proliferation up to 50 %, higher infection risk for patients treated with therapeutic Due to the sensitive and rapid test principle, PCR is established as the method of choice in research cells, unspecific positive results in animal control testing by stimulated immune systems, influence on but also for highly regulated testing procedures of pharmaceutical samples, such as in-process release virus proliferation and infection rates, disturbance of the hybridoma-technique and patch-clamp expe- testing or final release testing of vaccines and ATMPs. riments as well as a drastic decrease of electroporation rates. Mycoplasma can constitute up to 50 % Based on European Pharmacopoeia 2.6.7, traditional culture methods or indicator cell culture me- of the total protein and 15 - 30 % of the DNA isolated from a cell culture. These impurities will compli- thods can be replaced by PCR approaches, if a robust detection limit of 10 CFU/ml is shown. Both, our cate any downstream purification processes and cloning experiments. Venor®GeM Classic and Venor®GeM qEP are validated in compliance with the requirements of the EP 2.6.7. The validation reports are available on request. However, the validation data are for information Prevention only, as the EP 2.6.7 states: “Where commercial kits are used ..., documented validation points alrea- Unfortunately, ways of contamination are manifold and even laboratories with best practice are not dy covered by the kit manufacturer can replace validation by the user. Nevertheless, the performance safe. As mycoplasma are associated with specific host organisms, the source of contamination can of the kit with respect to its intended use has to be demonstrated by the user (e.g. detection limit, ro- be traced, e.g. contamination with Mycoplasma hyorhinis usually occurs by cross contamination from bustness, cross-detection of other classes of bacteria)”. lab to lab and rarely by trypsin used for cell transfer. Trypsin lyses mycoplasma particles within a short Please feel free to contact us, if you need assistance, e.g. providing a Validation Plan Template for time. On the other hand Acholeplasma laidlawii was confirmed as a contaminant of tryptone soya broth validating the release testing of ATMP´s. used in media products with surprising growth and long term survival abilities. Routine and reliable testing is the only way to prevent the cell culture user from loss and expenses. Not all test methods available on the market are equivalently suitable for specific sample material, show a large detection range or are sensitive enough.

10 11 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Mycoplasma Detection Kits Venor®GeM Classic

Our Mycoplasma Detection Kits employ PCR technology for rapid and reliable detection of more Features than 110 Mollicutes species, including Mycoplasma, Acholeplasma and Spiroplasma. All relevant Type of PCR For conventional endpoint PCR species known as contaminants in various in situ biologicals including cell cultures, culture media, cell preparations and virus stocks are detectable. One of the different types will fit each individual custom- Description Venor®GeM Classic is a basic PCR kit for fast, reliable and time-saving routine er’s need for a fast, reliable and time-saving routine monitoring! monitoring of mycoplasma contamination.

Recommended Use / Scope Applicable in research and industry for direct testing of cell cultures and biologicals. Not recommended for clinical diagnostics.

Kit Components Freeze-dried primer sets and nucleotides Kit version Description 10x reaction buffer optimized for MB Taq DNA Polymerase Freeze-dried positive control DNA Freeze-dried internal amplification control DNA qPCR research Recommended sample quantity Package Sizes Primer sets and nucleotides are prepared in aliquots of 25 tests. industry / pharma Extraction Control Conventional PCR Recommended for Recommended for EP 2.6.7 conformity Polymerase included Polymerase Cat. No. 11-1025 25 Tests Cat. No. 11-1050 50 Tests ® Venor GeM y n y n y y low y The classical version for gel eva- Cat. No. 11-1100 100 Tests Classic luation. 15 years of experience, Cat. No. 11-1250 250 Tests EP 2.6.7 compliant, always improved and at the state-of-the-art of DNA based mycoplasma detection – the optimal choice for money-savers! Result Evaluation Gel electrophoresis at endpoint of PCR

® Polymerase. We highly recommend our reliable hot-start MB Taq DNA Polymerase, Venor GeM y n n y y n low n The pre-casted version of Required Consumables Cat. No. 53-1050/100/200/250. (see page 31), PCR reaction tubes. Advance Venor®GeM is ready- for-gel. Just add the rehydration buffer and the sample into the pre-casted PCR tubes. After Optional for process validation and EP 2.6.7 compliant testing: cycling the PCR products can be loaded directly onto a gel, as marker and loa- Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; ding buffer are already included. The best version for time-savers! Cat. No. 11-1905) 10CFU™ Sensitivity Standards available for all EP listed mycoplasma species (see page 18) Venor®GeM y n n y y n high n Venor®GeM OneStep is all-in-one! OneStep Do you need a robust and reliable Required Lab Devices Regular PCR cycler, agarose gel electrophoresis and DNA staining system, work-horse? The Venor®GeM OneStep is the best choice as all reagents inclu- pipetting equipment, tube centrifuge ding the polymerase are freeze-dried and only need to be reactivated by adding the rehydration buffer. Best value for money! Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C

Venor®GeM n y y y n y high y qEP stands for qPCR-based, EP qEP EP 2.6.7 Compliance Yes, after appropriate sample preparation and process validation. 2.6.7 compliant mycoplasma tes- Validation report available on request ting. Venor®GEM qEP can be performed with any type of real-time PCR cycler able to detect the fluorescence dyes FAM™ and HEX™. Two protocols allow the fast screening of research samples or highly sensitive and robust testing of re- 4 3 2 M NTC NTC PC 10 10 10 10 copies Fig. Amplified PCR products are visualized by standard gel electrophoresis. gulated biopharmaceutical samples. 265 bp 191 bp

12 13 14 EP 2.6.7Compliance andStorage Shelf Life Required LabDevices Required Consumables Result Evaluation Sizes Package Kit Components Recommended Use/ Scope Description Type ofPCR Features Venor M NTC PC 105 ® GeM Advance 104 103 102 10 copies

265 bp No theindividualPCRtubesreagents of mustbeusedwithin1hour.rehydration Kit components+8°Cforatleast12months. After aremaintainableat+2to Tube centrifuge Pipetting equipment Agarose gel andDNAstainingsystem electrophoresis Regular PCRcycler Agarose gels andDNAstains PCR atendpointGel electrophoresis of Cat. No. 11-7240 Cat. No. 11-7096 Cat. No. 11-7048 Cat. No. 11-7024 Positive filledin0.2mlPCRreaction tubes controls, freeze-dried, Rehydration bufferincluding gel loadingbufferandrunningdye filledin0.2mlPCRreaction tubes freeze-dried, andinternal polymerase amplificationcontrol DNA,Primer sets,nucleotides, humansamples. ortestingof diagnostics biologicals. Intended for use research only. recommended Not for clinical cellculturesandculture-derived testingof fordirect Applicable inresearch ontheagarose gel.directly included in the buffer. reaction After thermal cycling the PCR can be loaded master mix.For additionalconvenience thegel loadingbufferanddyearealready a of preparealiquots assaytimewithoutneedto reagents reducethetotal to Venor®GeM For conventional endpoint PCR

191 bp Fig.

Amplified PCRproducts are visualized by standard gel electrophoresis. Advance contains PCR reaction tubespre-castedwithallPCRAdvance containsPCRreaction 240 96 48 24 Tests Tests Tests Tests Cell Culture Control Shelf Life andStorage Shelf Life Required LabDevices Required Consumables Result Evaluation Sizes Package Kit Components Recommended Use/ Scope Description Type ofPCR EP 2.6.7Compliance M NTC PC 104 PCR Cycler Validation 103 102 10 copies rehydration thereagentsrehydration below-18°C mustbestored Kit components +8°Cforatleast12months. After aremaintainableat+2to Tube centrifuge Pipetting equipment Agarose gel andDNAstainingsystem electrophoresis Regular PCRcycler tubes PCR reaction Agarose gels andDNAstains PCR atendpointGel electrophoresis of Cat. No. 11-8250 Cat. No. 11-8100 Cat. No. 11-8050 Cat. No. 11-8025 25tests. of inaliquots Primer andnucleotides waterPCR grade Freeze-dried control positive DNA Rehydration buffer inonetubeoptimized concentrations freeze-dried internal amplificationcontrolat Primer DNAandpolymerase sets,nucleotides, human samples. useonly.for research recommended ortestingof Not forclinicaldiagnostics cellculturesandbiologicals. Intended testingof fordirect Applicable inresearch sample orPositive Control DNAaddedandthesetup isready forPCR. to thesamplenumber, madeaccording to themix,aliquots buffer isadded mix.Theincludedrehydration reaction inafreeze-dried provided ready-to-use andtheinternalPCR. Primer,polymerase amplificationcontrol are nucleotides, Venor®GeM OneStep isacomplete kitallreagents whichincludes requiredfor For conventional endpoint PCR 265 bp No

191 bp Fig. Food & Water Amplified PCRproducts are visualized by standard gel electrophoresis. Assays 250 100 50 25 Tests Tests Tests Tests Nucleic Acid Nucleic Extraction Venor Cleaning Products DNA Standards & Standards DNA ® GeM OneStep Features Manufacturing Contract 15 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Venor®GeM qEP Venor®GeM Sample Preparation Kit

Features Features

Type of PCR Probe assay for qPCR Description 37% of all cell culture supernatants, and almost all of confluent cell culture supernatants, inhibit PCR. Proficiency studies have demonstrated the importance Description Venor®GeM qEP utilizes quantitative, real-time PCR for high quality and reliable of further DNA extraction for a sensitive PCR results even for unremarkable detection of mycoplasma contamination with a maximized sensitivity for sample materials. Mycoplasma species, A. laidlawii and S. citri. The kit was validated according to EP 2.6.7 "Mycoplasmas" in combination with EP 2.6.21 "Nucleic Acid Amplification The Venor®GeM Sample Preparation Kit provides samples highly compatible with Techniques" with respect to detection limit for all listed mycoplasma species, Minerva Biolabs Venor®GeM Mycoplasma PCR kits. A special protocol allows the specificity and robustness for cell cultures and autologous cell transplants (e.g. purification of the samples in order to meet the high demands of the EP 2.6.7. chondrocytes). The sample DNA is eluted in a volume of 60 µl in a high concentration and purity for maximum sensitivity of the PCR. The kit works with DNA extraction columns which are directly suitable for the treatment of up to 200 µl of your sample. Recommended Use / Scope Venor®GeM qEP is used for direct detection of Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) in cell cultures and cell culture derived biologicals, like autologous transplants (ATMPs), sera, cell culture media and therapeutic Recommended Use / Scope For DNA extraction from: antibody formulations, according to European Pharmacopoeia (EP) 2.6.7 Cell culture supernatants including cells and cell debris Mycoplasmas. Not applicable for clinical diagnostics. ATMPs Samples with polymers and glycerine (e.g. cryo conservation media) Cell culture media Kit Components Freeze-dried primer/nucleotides/probes/polymerase mix, aliquoted for 25 tests Protein solutions, incl. antibodies and enzymes internal amplification control DNA usable as DNA extraction control rehydration buffer, PCR grade water freeze-dried positive control DNA Kit Components Spin columns Collection tubes Package Sizes Cat. No. 11-9025 25 Tests Conditioner Cat. No. 11-9100 100 Tests Binding buffer Cat. No. 11-9250 250 Tests Wash and elution buffers

Result Evaluation Cycler based, real-time PCR Package Sizes Cat. No. 56-1010 10 extractions Cat. No. 56-1050 50 extractions Required Consumables PCR reaction tubes. Cat. No. 56-1200 200 extractions Optional for process validation and EP 2.6.7 compliant testing: Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; Required Consumables Ethanol is required for the reconstitution of the wash buffer but not included in Cat. No. 11-1905) the kit. Microcentrifuge vials (1.5 ml) are needed for DNA elution. For validation and performance control: Quantification Standards for all EP listed mycoplasma species provide titrated At protein concentrations above 10 mg/ml in the sample pretreatment with DNA for the quantification of the mycoplasma DNA load in the sample (see page 74). Proteinase K is strongly recommended (Cat. No. 11-9905). 10CFU™ Sensitivity Standards for validation and performance control (see page 18) Shelf Life and Storage Stored at room temperature. Required Lab Devices qPCR cycler with filters for FAM™ and HEX Pipetting equipment Compliance The protocol allows purification of the samples to meet the EP 2.6.7 criteria. Centrifuge for 1.5 ml reaction tubes

Shelf Life and Storage Kit components must be stored at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C.

EP 2.6.7 Compliance Yes, after appropriate sample preparation and process validation. Validation report available on request

16 17 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

10CFU™ ​Mycoplasma Sensitivity Standards

Features Features

Description European Pharmacopoeia 2.6.7 Mycoplasmas requires a sensitivity of 10 CFU/ml Selection Cat. No. 102-1003 Mycoplasma arginini sample volume for NAT-based methods like PCR to replace the traditional culture Cat. No. 102-2003 Mycoplasma orale method. This feature of the test method must be shown by the performing lab Cat. No. 102-3003 Mycoplasma gallisepticum as part of the robustness testing in presence of the sample matrix. As most cell Cat. No. 102-4003 Mycoplasma pneumoniae culture labs and production facilities cannot accept vital mycoplasma in their Cat. No. 102-5003 Mycoplasma synoviae facility or do not have access to a microbiology lab able to cultivate mycoplasma, Cat. No. 102-6003 Mycoplasma fermentans 10CFU™ Mycoplasma Sensitivity Standards allow safe and reliable validation of Cat. No. 102-7003 Mycoplasma hyorhinis the procedure. Cat. No. 102-8003 Acholeplasma laidlawii Cat. No. 102-9003 Spiroplasma citri The mycoplasma have been cultivated in culture broth as described in EP 2.6.7, Cat. No. 102-0002 Mycoplasma Set, all EP 2.6.7 listed species titrated immediately in culture broth and plated for quantification in colony forming units (CFU/ml). Each dilution series has been performed in multiple by Result Evaluation Use of a suitable Mycoplasma PCR kit, different operators for highest precision. The mycoplasma broth was harvested in e.g. Venor®GeM Classic (see page 13) or Venor®GeM qEP (see page 16) the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles and correspondingly a high GU:CFU ratio. All strains have been obtained from official culture collections and cultivated in low passages. Required Consumables None

Recommended Use / Scope For validating the robustness and sensitivity of NAT-based mycoplasma test Required Lab Devices Regular lab equipment (centrifuge, pipettes, etc.) methods in presence of the sample matrix. Each vial contains 10 CFU of inactivated mycoplasma. By adding the sample Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months matrix of interest, a sample according to EP 2.6.7 is prepared which has to be tested positive by the method applied. Obviously, the inactivated sample material is not suitable for the culture method anymore. As a result of proficiency tests on NAT-methods for mycoplasma detection it became obvious that in means of highest sensitivity DNA extraction is indispensible. The extract can directly be used for PCR.

Kit Components 3 vials with 10 CFU of the corresponding mycoplasma species 2 negative control vials

For the mycoplasma set: 2 vials with 10 CFU of each mycoplasma species listed in the EP 2.6.7 2 negative controls

1 x positive control

6 x 10 CFU

Fig. 10 CFU have been resuspended in cell culture medium, 200 µl DNA extracted with the Venor®GeM Sample Preparation 2 x negative control Kit and mycoplasmal DNA amplified with Venor®GeM qEP. PCR was performed on a MxPro – Mx3005P®.

18 19 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Mycoplasma Elimination Reagents Benefits

Mycoplasma are parasitic bacteria which are either present in the supernatant of a cell Universal and highly effective for mycoplasma culture or attached to the surface of the host cell. The lack of a cell wall makes myco- Mynox® is the first biological reagent that eliminates mycoplasma by killing and not just inhibiting their plasma resistant to many antibiotics. Active penetration and intracellular existence of growth. Mynox® is effective against any type of microorganisms belonging to the group of Mollicutes, mycoplasma is scientifically discussed and not generally accepted for cell lines routinely used in the including Mycoplasma, Spiroplasma, Acholeplasma, and Ureaplasma. cell culture lab. Mynox® is a biological agent that integrates selectively into the mycoplasma membrane Even for virus stocks and compromises its integrity. The result is an osmotic influx that leads to the complete Mynox® is the only anti-mycoplasma reagent that can be used to clean stocks of non-enveloped viru- disintegration of the mycoplasma membrane. (see figure below) With mycoplasma eradicated, cells can ses directly. immediately return to their native morphology and normal proliferation rates. Fast Mynox® has been shown to be effective with only one treatment.

Universal for cell lines Mynox® can be used for any cell type without restriction (permanent cell lines like Vero, BHK21, GBK, ML, Hep2, 293, CRFK, H9, Molt4, MT-4, Jurkat, or even stem cells) as well as virus stocks (e.g. SHV-1, BHV-1, HSV-1, VSV, SFV, FCV, MEV etc.).

Save to cells To date, Mynox® has not been shown to cause any changes in normal cell characteristics. The cytoto- xicity of Mynox® is low. In the rare case of cytotoxic effects,Mynox® is easily removed after treatment by replacing the culture medium.

Interoperable Mynox® can be used with antibiotic selection agents, for example G418, blastocyclin, and hygromycin. It also does not interfere with killer genes turned on by tetracyclin or doxycyclin. A

B Fig. Electron micrograph showing the effects of Mynox® when applied to contaminated cell cultures. (A) Mycoplasma contaminated cell culture before treatment.

(B) With one application of Mynox® membranes of all mycoplasma are 30 Fig. Cytotoxicity of Mynox® Gold on contaminated cells. Adherent cell lines (Vero, ML/S 20 destroyed while the membrane of the mammalian cell is unaffected. ® 10.3 % MDBK and RK13) were treated with Mynox Gold according to the protocol for 4 days. The Black arrows indicate mycoplasmas, white arrows indicate parts of a 10 5 % 6.5 % 0 % cultures were inactivated and stained as described by Flick & Gifford. Untreated cultures 0

mammalian cell. (%) Cytotoxicity Vero ML/S MDBK RK13 had been used as reference (100 %).

20 21 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Mynox® Mynox® Gold

Features Features

Description The classic Mynox® is an antibiotic-free formulation; its effect is based on a Description Mynox® Gold represents the further development of the classical Mynox®. biophysical mechanism, thus there is no development of resistant strains. Mynox® Gold is a combination of a standard antibiotic and the biological Mynox® Mycoplasma are permanently destroyed within 2-3 hours. reagent. One application comprises of a starter and a main treatment. The starter treatment eliminates most of the mycoplasma particles without harming the cells. Benefits Free of antibiotics. The main treatment kills all remaining mycoplasma.

Recommended Use / Scope Mynox® is intended for research use only. Not applicable for clinical treatment. Benefits No cytotoxicity - cytotoxicity is basically not detectable for most cell types. Most The direct treatment of enveloped viruses is not possible. cell lines do not show any changes in morphology during treatment. Low resistance risk - due to the combination of an antibiotic and a reagent Kit Components Mynox® is a sterile, ready-to-use solution, aliquoted per tube for single use, 200 showing a biophysical mode of action directly eliminating the mycoplasma, µl per vial. formation of resistances against Mynox® Gold is most unlikely.

Package Sizes Cat. No. 10-0200 2 applications Highly effective - the ratio for a permanent eradication is close to 100 %. Cat. No. 10-0500 5 applications Cat. No. 10-1000 10 applications Recommended Use / Scope Mynox® Gold is intended for research use only. Not applicable for clinical 1 application can be used to cure one cell culture permanently from mycoplasma treatment. Not applicable for the direct treatment of cells used as host systems contamination. for enveloped viruses or harboring Chlamydia or other bacteria. The antibiotic portion of the product might affect the intracellular microorganisms. Result Evaluation Elimination success should be verified with a suitable mycoplasma detection system, e.g. Minerva Biolabs’s Venor®GeM Mycoplasma PCR Detection Kits Kit Components 1 application of Mynox® Gold contains 1 vial for the starter treatment and 3 vials (Page 13-16). for the main treatment. Each vial contains 500 µl of a sterile, ready-to-use solution.

Required Consumables 6-well tissue culture plate or small tissue culture petri dish (6 mm Ø) Package Sizes Cat. No. 10-0201 2 applications Regular cell culture plastics. Cat. No. 10-0501 5 applications Cat. No. 10-1001 10 applications Required Lab Devices Regular cell culture equipment (incubator, centrifuge, pipettes, etc.). 1 application can be used to cure one cell culture permanently from mycoplasma contamination. Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. Result Evaluation Elimination success should be verified with a suitable mycoplasma detection system, e.g. Minerva Biolabs’s Venor®GeM Mycoplasma PCR Detection Kits. (see page 13-16)

Required Consumables 6-well tissue culture plate or small tissue culture petri dish (6 mm Ø) Regular cell culture plastics.

Required Lab Devices Regular cell culture equipment (incubator, centrifuge, pipettes, etc.).

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months.

22 23 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Onar® Bacteria – Bacteria Detection Kit Onar® Bacteria

Bacteria are frequently found as contaminants in cell cultures. Studies have identified an overall 6 % incidence of bacterial contamination of cell cultures examined. Many cell cultures lack visual signs of bacterial contamination, by microscopy as well as culture medium indicator. Moreover, it has been demonstrated that standard antibiotics are ineffective against resistant bacterial infection and also have a strong impact on cell growth and differentiation. Features ® Onar Bacteria utilizes the polymerase chain reaction (PCR) for highly sensitive detection of Description PCR kit for conventional, endpoint PCR of bacteria in various in situ biologicals bacterial contamination in various in situ biologicals including cell cultures and virus stocks. including cell cultures and virus stocks. The primer set is specific to a highly conserved region within the 16S ribosomal RNA gene in the bacteria genome. This allows for detection of all bacteria species tested thus far and usu- Recommended Use / Scope Applicable in research and industry for direct testing of cell cultures and ally encountered as airborne contaminants in cell cultures. Eukaryotic DNA is not amplified by biologicals. For QA application specific validation might be required. Intended Onar® Bacteria. The Primer/Nucleotide Reaction Mix already provides an Internal Control DNA as an for research use only. Not recommended for clinical diagnostics or testing of essential tool for successfully executed reactions. human samples.

Kit Components Freeze-dried Primer/Nucleotide Mix including the internal amplification control DNA Benefits and polymerase Rehydration buffer Sensitive Freeze-dried positive control DNA Detection of 10 copies per sample volume, corresponding to ~40 fg bacterial DNA (e.g. Bacillus subtilis). PCR grade Water

Broad Range Package Sizes Cat. No. 12-1025 25 Tests Detection of more than 45 bacteria genera: Actinomyces, Bacillus, Enterococcus, Escherichia coli, Fuso- Cat. No. 12-1050 50 Tests bacterium, Klebsiella, Lactobacillus, Micrococcus, Mycobacterium, Peptostreptococcus, Pseudomonas, Por- Cat. No. 12-1100 100 Tests Cat. No. 12-1250 250 Tests phyromonas, Prevotella, Salmonella, Serratia, Staphylococcus, Streptococcus, etc. Primer/Nucleotides/Polymerase sets are prepared in aliquots for 25 tests.

Reliable and Rapid Result Evaluation Gel electrophoresis at endpoint of PCR The kit contains positive control DNA, and an internal control to eliminate the possibility of false-nega- tive results. Hands-on time less than 40 min. Required Consumables PCR reaction tubes Convenient The Primer/Nucleotide Reaction Mixes are always aliquoted for long time stability and easy handling. The Required Lab Devices Regular PCR cycler Agarose gel electrophoresis and DNA staining system protocol only requires a few pipetting steps which reduces time, risks for mistakes and contamination.The Pipetting equipment kit works with samples prepared by boiling the supernatant of cell cultures or other sample material. Tube centrifuge Only complex matrices need to be prepared by DNA isolation using common methods.

Shelf Life and Storage Components are maintainable at +2 to +8 °C for at least 12 months. After rehydration Clear the reagents must be stored below -18 °C. A clear and easily interpretable result is obtained with one PCR reaction. No subsequent and laborious

detection or cost-intensive devices are required. 210 bp 468 bp

Stable 1 kb DNA Ladder The relevant kit components are freeze-dried and need to be rehydrated with a supplied buffer to redu- positive control DNA ce shipping costs and increase product stability negative sample/internal control 1000 copies (positive sample) Contamination prevention 100 copies (positive sample) The kit can also be used with UNG for carry-over prevention. UNG is not included. 10 copies (positive sample) 1 copy Fig. The amplified PCR products are visualized by standard gel electrophoresis.

24 25 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Decontamination, Disinfection, and Prevention ZellShield® The Cell Culture Contamination Preventive

There are manifold ways how contaminations either through cell culture setup, the media components Features or the equipment can impact your results: Description ZellShield® protects cell cultures from a broad range of common contaminants. It is speculated that more than 60-70 % of the cell cultures worldwide are contaminated with myco- The extremely powerful combination of innovative antibiotics is blocking the plasma. Mycoplasma are the smallest self-replicating organisms (0.1 to 0.8 μm) known thus far. Myco- bacterial DNA synthesis, the protein biosynthesis or shows macrolidic properties. plasma lack a cell wall which makes them resistant to cell wall specific antibiotics, such as penicillin. These bactericidal features allow the permanent removal of contaminants from Also other microorganisms like bacteria, fungi and viruses are common contaminations of cell cultures, the culture. The use of old fashioned antibiotics like penicillin/streptomycin, cell culture equipment and water reservoirs. Water required for water and heating baths, reservoirs and nystatin or amphotericin B is no longer required!

in CO2 incubators is preset to microbial contamination due to ideal environmental conditions. For these reasons it is of special interest and need to take any preventive action to avoid contami- Benefits Broad applicability nations with unwanted microorganisms impacting your results or risking to lose your valuable cell cul- ZellShield® can be used for permanent cell cultures as well as for the protection tures: of freshly prepared primary cells. No cell toxicity • ZellShield® protects cell cultures from a broad range of common contaminants. Up to date, no cytotoxic effect on various cell lines treated nor interference with ZellShield® is active against most intracellular and extracellular growing gram negative and gram endotoxin tests have been reported if used as described. positive bacteria, mycoplasma, protozoon, fungi and yeast. Specificity ZellShield® is active against most intracellular and extracellular growing gram • WaterShield™ protects the water in the reservoir from microbial growth. WaterShield™ can be used in negative and gram positive bacteria, mycoplasma, protozoa, fungi, and yeast. any kind of laboratory water reservoirs and is compatible with common work surfaces. Easy to use Simply add ZellShield® directly to a freshly prepared cell culture or premix with • Mycoplasma-Off™ is a highly effective solution for cleansing and disinfection of all suitable labora- the cell culture medium. The mix is stable for up to 4 weeks at 2-8° C. tory surfaces and apparatus. Mycoplasma-Off™ is outstandingly safe in use possessing not only a Stability strong mycoplasmacidal effect, but also being effective against bacteria, yeasts and viruses: My- The reagent is stable and active during typical incubation periods and conditions. coplasma-Off™ has been proven to be effective against bacteria such as Staphylococcus aureus, Low Resistance Risk Enterococcus hirae, Escherichia coli, , Pseudomonas aeruginosa, Candida albicans, The well selected antimicrobials show an extremely low resistance bias. Their BVDV, Poliovirus, Adenovirus, Polyomavirus SV40, Norovirus and Vacciniavirus. combined activity reduces the probability for the survival of resistant mutants.

Recommended Use / Scope Applicable in research and industry for cell cultures only. Not recommended for clinical applications.

Kit Components The easy applicable 100x aqueous solution is sterile filtrated and ready-to-use.

Package Sizes Cat. No. 13-0050 50 ml Cat. No. 13-0150 3x 50 ml

Result Evaluation None

Required Consumables Cell culture equipment

Required Lab Devices Pipetting equipment

Shelf Life and Storage Shipped on cool packs and should be stored in the dark below -18 °C. Stable for at least 12 months.

26 27 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Mycoplasma-Off™ Mycoplasma-Off™ Wipes Disinfection Spray for the Removal of Mycoplasma Quick and Easy Cleaning & Disinfection

Features Features

Description Mycoplasma-Off™ is used for cleaning and disinfection of all laboratory surfaces Description Mycoplasma-Off™ Wipes are the simple solution for cleaning and disinfecting and apparatus, including clean benches, incubators, work benches, cell storage a variety of laboratory surfaces at the same time. There’s no need for multiple boxes and liquid nitrogen containers from mycoplasma contamination. products when you have the convenience of a simple-to-use wipe. When you use a sponge or even paper towel, you can spread bacteria from one surface to another. Benefits Rapid Instead of killing germs, you are pushing them around and potentially increasing Mycoplasma-Off™ affects mycoplasma immediately. Within seconds mycoplasma the contaminated surface area. are completely eradicated. Non-corrosive and non-carcinogenic Benefits Broad Applicability Mycoplasma-Off™ is an alcohol-based, non-corrosive and non-carcinogenic. Mycoplasma-Off™ Wipes can be used on hard, nonporous surfaces in every room of the lab including safety cabinets, pipettes, cell storage boxes, lab equipment exterior Broad spectrum of antimicrobial activity (like liquid nitrogen containers), incubator interior, and many more. Bactericidal, fungicidal, and virucidal! Mycoplasma-Off™ is outstandingly safe in use. It possesses not only a strong mycoplasmacidal activity but was also found to Non-corrosive and non-carcinogenic Mycoplasma-Off™ Wipes are made with a bleach-free formula leaving a light, be effective against asStaphylococcus aureus, Enterococcus hirae, Escherichia clean scent every time you wipe off a surface.Mycoplasma-Off™ Wipes are soaked coli, Proteus mirabilis, Pseudomonas aeruginosa, Candida albicans, BVDV, with an alcohol-based, non-corrosive and non-carcinogenic solution. They can Poliovirus, Adenovirus, Polyomavirus SV40, Norovirus and Vacciniavirus. be used as a routine contamination control program or for known or suspected Convenient and ready-to-use mycoplasma challenges. Mycoplasma-Off™ is a ready-to-use solution supplied in a refillable spray bottle use Broad inactivation range of Mycoplasma-Off™ is fast, easy and ideal to maintain a clean work area. Mycoplasma-Off™ Wipes kill mycoplasma within seconds. Wipes are also effective against common bacteria such as Staphylococcus aureus, Enterococcus Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical applications. hirae, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Candida Use as directed. Always test a small area first for stability and coloration. albicans, BVDV, Poliovirus, Adenovirus, Polyomavirus SV40, Norovirus and Mycoplasma-Off™ should not be used on alcohol sensitive surfaces like acrylic Vacciniavirus. and fiberglass. Easy to use It’s simple. Wipe surface clean with Mycoplasma-Off™Wipes. Let it air-dry. Convenient Kit Components Ready-to-use formulation in a spray bottle or refill bottles. where spraying is not applicable (e.g. covers of electronic devices, electronic pipettes).

Package Sizes Cat. No. 15-1000 1000 ml spray bottle Recommended Use / Scope Applicable in research and industry, only. Not recommended for clinical Cat. No. 15-5000 5x 1000 ml refill bottle applications. Use as directed. Always test a small area first for stability and coloration. Mycoplasma-Off™ Wipes should not be used on alcohol sensitive Result Evaluation None surfaces like acrylic and fiberglass.

Required Consumables Paper towels Kit Components Single use wipes in a product safety sachet.

Required Lab Devices None Package Sizes Cat. No. 15-1001 120 wipes in a dispenser box Cat. No. 15-5001 5x 120 refill sachets Shelf Life and Storage Stable at room temperature for at least 12 months. Required Consumables None

Required Lab Devices None

Shelf Life and Storage Stable at room temperature for at least 12 months.

28 29 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

WaterShield™ MB Taq DNA Polymerase Water Disinfection Additive hot start

Features Features

Description Water required for CO2 incubators is preset to microbial contamination due to Description MB Taq DNA Polymerase is a highly processive 5´→3´ polymerase with no ideal environmental conditions. WaterShield™ protects the water in the reservoir 3´→5´ exonuclease (proofreading) activity. At 72 °C and around pH 9 conditions, from microbial growth. MB Taq DNA Polymerase reaches its highest level of activity, capable of amplifying a standard 1 kb strand of DNA in approximately 30 seconds. The Taq‘s activity is Benefits Broad Applicability blocked at ambient temperature, e.g. while preparing your sample. The inhibition WaterShield™ can also be used in regular water/heating baths and is compatible of the Taq polymerase is completely reversed when the temperature is above 70 with common work surfaces (e.g. tin plated iron, chrome, nickel steel, high grade °C. Complete activation of the polymerase is achieved at 94 °C for 2 min. MB Taq steel and copper). DNA Polymerase is supplied with a 10x buffer for maximal yield and sensitivity which should fit most standard applications. No cell toxicity Thewater additive contains quaternary ammonium compounds and surfactants as disinfecting and cleaning ingredients, but no aldehydes, phenols, alcohols or Recommended Use / Scope Routine and multiplex PCR; real-time PCR; T/A cloning; DNA labeling with biotin, azides. These reagents are not vaporizing and are therefore safe to the cells. All digoxygenin or radioactive nucleotids; sequencing of double or single stranded ingredients are safe to humans and do not cause any irritating effects to the skin DNA when used in the recommended concentration. No odor annoyance is noticeable. Broad inactivation range Kit Components MB Taq DNA Polymerase, supplied in 10 mM Tris-HCl (pH 7.0), 50 mM KCl, 0.1 WaterShield™ is active against most bacteria, mycoplasma, protozoa, algae, mM EDTA, and 50 % (v/v) glycerol. fungi and yeast. 10x reaction buffer. 100 mM MgCl2 solution. Easy to use If the polymerase is used in combination with Venor®GeM Classic the buffer Simply add one bottle (5 ml) of WaterShield™ directly to one liter of deionized water. provided with the polymerase is not required. Stability The reagent is usually active for 4 weeks. A blue stain indicated the status of the Package Sizes MB Taq DNA Polymerase available in concentrations of 1 u/μl and 5 u/μl. additive. In case of increasing bioburden a renewal of the water and the additive is required. 1 Unit/μl Cat. No. 53-1050 50 Units Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical Cat. No. 53-1100 100 Units applications. Do not use with acrylic glass or aluminum surfaces. Cat. No. 53-1200 200 Units Cat. No. 53-1250 250 Units Kit Components The easy applicable 200x aqueous solution is provided in aliquots of 5 ml ready- to-use for 1 liter of water. 5 Unit/μl Cat. No. 53-0050 50 Units Cat. No. 53-0100 100 Units Package Sizes Cat. No. 15-3015 30x 5 ml Cat. No. 53-0200 200 Units Cat. No. 15-3020 3x 50 ml Cat. No. 53-0250 250 Units Cat. No. 15-3050 500 ml

Shelf Life and Storage Components must be stored below -18 °C. Shipment on cool packs. The product Result Evaluation Color change is stable for at least 12 months.

Required Consumables None

Required Lab Devices None

Shelf Life and Storage Shipped and storage at room temperature. Stable for at least 12 months.

30 31 PCR Cycler Validation

32 33 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Introduction PCR Cycler Check™

False negative PCR results or unspecific amplifications might be caused by a defect PCR cycler. Both events are highly critical for Good Laboratory Practise. Verification of the correct temperature control Features of the used equipment is usually a stressful but essential issue. To comply with quality management Type of Thermal Cycler Traditional, block heating, thermal cyclers systems is not easy to fulfil for PCR cyclers. Electronic temperature sensors offered for purchase or as service usually measure the temperature homogeneity in a cycler block, only, which does not neces- Description PCR Cycler Check™ is available as OneStep and Advance version. PCR Cyc- sarily reflect all parameters which need to be controlled by the cycler and can fail to provide reliable ler Check™ OneStep is a ready-to-use lyophilized master mix in a tube while PCR results. Only a reference setup can investigate all relevant parameters of the process reliably. the Advance version is pre-aliquoted and lyophilized in high profile stripes The PCR Cycler Check™ kits allow a realistic verification of block and air heated PCR cyclers for ins- ready upon rehydration with buffer. tallation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) according to legal requirements, like ISO 17025, EN 45001, ISO 13485, ISO/TS 20836:2007, GLP, GMP and others. Recommended Use / Scope Applicable with any block PCR cycler in research or industrial quality assurance The PCR Cycler Check™ series provides temperature sensitive PCR reactions to monitor an upper and lab in order to fulfil legal requirements for the reliability testing of instruments used for analysis (ISO 17025, EN 45001, ISO 13485, GLP, GMP). lower temperature range in one PCR reaction. The primer sequences and the PCR protocol were desig- ned to react extremely sensitive on fluctuations of more than 2 °C within the cycler protocol with a drop out of amplification. This way the temperature homogeneity, the precision of the temperature control Kit Components Advance OneStep Primer sets, template, nucleotides, Primer sets, template, nucleotides, and and the timing can be verified. In addition, the pre-adjusted target concentrations are only amplified at and polymerase, lyophilized, filled in polymerase lyophilized in one tube. high PCR efficiencies as an additional indicator for accurate temperature control of the thermal cycler. 0.2 ml PCR reaction tubes (stripes). Rehydration buffer, gel size marker for Rehydration buffer, gel size marker for result interpretation. result interpretation.

Package Sizes Cat. No. Cat. No. 57-2102 6 strips, 8 vials each 57-2103 100 reactions

Result Evaluation Gel electrophoresis at endpoint of PCR

Required Consumables Reagents for agarose gel PCR reaction tubes electrophoresis Reagents for agarose gel electrophoresis

Required Lab Devices Tube centrifuge, Pipetting equipment, PCR cycler. Agarose gel electrophoresis and documentation system

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months.

After rehydration of the individual PCR After rehydration the reagents must be tubes the reagents must be used within stored below -18 °C 1 hour.

34 35 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

qPCR Cycler Check™ Color Compensation Kit

Features Features

Type of Thermal Cycler Real-time PCR (qPCR) thermal cyclers with optical unit Type of Thermal Cycler Real-time PCR (qPCR) thermal cyclers with optical unit

Description The qPCR Cycler Check™ kit is based on the well-established PCR Cycler Check™ Description The Color Compensation Kit is designed for generating color compensation files on temperature sensitive PCR but additional temperature sensitive probes allow you qPCR cyclers to allow proper interpretation of multiplex experiments. To generate to monitor quantitative realtime PCR cycler precision in one PCR reaction. Probes a color compensation object, the labeled calibration dyes are used in an initial of each amplification system are labeled with different fluorescent dyes to allow color compensation run. The calibration dyes contain labeled oligonucleotides for individual evaluation. the determination of crosstalk corresponding to each individual dye being used in a multiplex assay, and a blank reaction buffer without dye for the determination Recommended Use / Scope Applicable for any real-time qPCR cycler in research or industrial quality assurance of background fluorescence of the buffer. lab in order to fulfil legal requirements for the reliability testing of instruments used for analysis (ISO 17025, EN 45001, ISO 13485, GLP, GMP). The kit can be used Recommended Use / Scope As real-time qPCR cyclers may vary in their fluorescence detection sensitivity, with block as well as with air heating systems. color compensation experiments must be performed on each specific multiplex PCR instrument. In the case of overcompensation or remaining crosstalk it is Kit Components Freeze-dried primer/probe sets, polymerase and nucleotides recommended to adjust the calibration dye concentration used for performing Rehydration Buffer the color compensation experiment to result in an equal level of (absolute) fluorescence signal.

Package Sizes Cat. No. 57-2202 100 reactions Kit Components Calibration dyes for different wavelengths, freeze-dried Rehydration buffer Result Evaluation Measuring fluorescence signal with qPCR cycler. Package Sizes 10 calibrations, 25 µl each Required Consumables qPCR reaction tubes and caps Cat. No. 57-0110 FAM™, ROX™ and VIC® Cat. No. 57-0210 FAM™ Required Lab Devices Tube centrifuge Cat. No. 57-0310 TAMRA™ Pipetting equipment Cat. No. 57-0410 ROX™ qPCR cycler with filters for the detection of FAM™, VIC™ and ROX™ dyes Cat. No. 57-0510 VIC® Cat. No. 57-0610 SYBR® Green Cat. No. 57-0710 JOE™ Shelf Life and Storage Components are maintainable at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C Cat. No. 57-0810 CY-3™ Cat. No. 57-0910 CY-5™ Cat. No. 57-1010 Texas Red®

Result Evaluation Generation of color compensation files

Required Consumables qPCR reaction tubes and caps

Required Lab Devices Tube centrifuge, pipetting equipment, qPCR cycler

Shelf Life and Storage Components are maintainable at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C

36 37 Food and Water Testing

38 39 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

AquaScreen® Benefits

AquaScreen® is a test system for quantitative detection of water pathogens. AquaScreen® combines Very sensitive water filtration, lysis of the collected microorganisms, DNA extraction and elution of the DNA in mini- Detection accomplished with less than 500 microorganisms per sample volume of 1000 ml. mal volumes ready for subsequent PCR analysis. Ease of use Step 1: Preparation of the Sample Material Sample preparation includes simple water filtration and DNA extraction prior to direct PCR analysis. Drinking water, condensed water from cooling systems, bathing or pool water, and waste water released from suspended particles can be used as sample materials. The sample conditioning affects the re- Instrument compatibility liability of the test findings and must be in accordance with the guidelines ISO Norm 11731/11731-2. Our assays work with most available qPCR cyclers with the standard filters for FAM™ and ROX™/Texas Preservation with chemical or physical means is not possible as intact microorganisms are needed Red® if not specified otherwise. All kits are tested on the following qPCR devices: ABI Prism®7500, Ro- for the filtration procedure. torGene®6000, Mx3005P®, LightCycler® 1.2. With suspended particles or fixed volatile contents, contaminated water samples can be purified by prior filtration with a paper folded filter. The samples may not be centrifuged for purification. The testing One extract – multiple parameters procedure requires 100-1000 ml. The AquaScreen® FastExtract procedure is very simple and represents an inexpensive method to obtain suitable template DNA for routine PCR tests. In addition one extract can be used for PCR reactions with Step 2: PCR Application different specificities, so that multiple microorganisms can be analyzed in parallel and on users’ choice. TheAquaScreen® qPCR kits are assays for quantitative detection of Legionella pneumophila, Legionella species, Pseudomonas aeruginosa and Escherichia coli in water samples. The test is based on quanti- Fast tative real-time PCR (qPCR) which allows for highest specificity and sensitivity. The corresponding PCR The fast extraction procedure in combination with the rapid PCR method allows detection of patho- mix contains a primer/probe set specific for the microorganism to be detected and emits a fluorescent genic organisms (including those that may be non-culturable) in industrial and environmental water light at ~520 nm. The kit includes an internal control that is detected by another probe emitting light samples within a few hours. at ~610 nm. The internal control is constructed as a homologous control containing primer binding sites identical to the target but with a unique internal sequence. In addition, a surrogate spike can be Recognizes VBNC (Viable But Not Culturable) used to monitor the pre-analytical process. By using the supplied internal control or alternatively the Free DNA of dead and already lysed microorganisms in the sample pass through the surrogate spike, false negative results (e.g. due to inhibition of the reaction by the sample matrix) can membrane filter and are not detectable in the test system. The test detects both “viable and cultura- be excluded individually for each sample. ble” and “viable but not culturable” (VBNC) legionella. The effect of hygiene measures like heat treat- ment can be monitored instantly.

Reliable The extraction kit contains only high quality products, including amongst others membrane filters, spin columns and buffers. All components have been pre-tested for DNA contamination.

Clear A clear and easily interpretable result is obtained with one PCR reaction. No subsequent and laborious detection or cost-intensive devices are required.

Stable All PCR kits are freeze-dried and need to be rehydrated with a supplied buffer to reduce shipping costs and increase product stability.

Contamination prevention All PCR kits can also be used with UNG for carry-over prevention (UNG is not included).

40 41 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

AquaScreen® FastExtract AquaScreen® Legionella species

Features Features

Description Rapid DNA Extraction from water samples Type of PCR Quantitative real-time PCR (qPCR)

Recommended Use / Scope AquaScreen® FastExtract can be used with your established suction device (47 Description The AquaScreen® Legionella species qPCR Detection Kit is used for DNA sam- mm frit) for the extraction of legionella and other microbial contaminations. ples prepared with the AquaScreen® Fast Extract for quantification of Legionella AquaScreen® FastExtract is optimized for high flow and throughput and provides in waters samples. The supplied primer set is specific for a braod range of legio- high quality DNA for subsequent PCR analysis. nella species, but does not detect other water born bacteria as required by ISO/ TS 12869:2012. Kit Components Membrane filters Incubation dishes Recommended Use / Scope Applicable for water testing as described in ISO/TS 12869:2012, in research and Incubation, collection and sample storage tubes industry for QA testing of process water. Not recommended for clinical diagnos- Lysis, binding buffer, wash, and elution buffers tics, testing of human samples or pharmaceutical products.

Package Sizes Cat. No. 32-1010 10 extractions Kit Components Freeze-dried primer, probes, nucleotides and polymerase Cat. No. 32-1050 50 extractions Rehydration Buffer Freeze-dried Positive Control DNA Required Consumables Ethanol (96-100 %) Freeze-dried Internal Amplification Control

Required Lab Devices Vacuum pump Package Sizes Cat. No. 33-2025 25 reactions Micro centrifuge Cat. No. 33-2100 100 reactions Filtration system, 47 mm frit Cat. No. 33-2250 250 reactions Pipetting equipment and filtered tips Primer sets and nucleotides are prepared in aliquots for 25 tests. Incubator (37 °C for petri dishes, 70 °C for reaction tubes) Required Consumables qPCR reaction tubes and caps Shelf Life and Storage Kit components are maintainable at room temperature for at least 12 months. Optional: For calibration we recommend our Legionella pneumophila PCR Quan- tification Standard (Cat. No. 52-0101).

Compliance AFNOR XP T90-471 and ISO/TS 12869:2012 Required Lab Devices Pipetting equipment qPCR cycler with filter sets for FAM™ and ROX™

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re- hydration the reagents must be stored below -18 °C

Compliance AFNOR XP T90-471 and ISO/TS 12869:2012

42 43 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

AquaScreen® AquaScreen® Legionella pneumophila Pseudomonas aeruginosa

Features Features

Type of PCR Quantitative real-time PCR (qPCR) Type of PCR Quantitative real-time PCR (qPCR)

Description The AquaScreen® Legionelle pneumophila qPCR Detection Kit is used for DNA Description TheAquaScreen® Pseudomonas aeruginosa qPCR Detection Kit is used for DNA samples prepared with the AquaScreen® FastExtract for quantification of Legio- samples prepared with the AquaScreen® FastExtract for quantification of Pseu- nelle pneumophila in water samples. domonas aeruginosa in water samples.

Recommended Use / Scope Applicable in research and industry for QA testing of household and process wa- Recommended Use / Scope Applicable in research and industry for QA testing of household and process wa- ter. Not recommended for clinical diagnostics, testing of human samples or phar- ter. Not recommended for clinical diagnostics, testing of human samples or phar- maceutical products. maceutical products.

Kit Components Freeze-dried primer, probes, nucleotides and polymerase Kit Components Freeze-dried primer, probes, nucleotides and polymerase Rehydration Buffer Rehydration Buffer Freeze-dried Positive Control DNA Freeze-dried Positive Control DNA Freeze-dried Internal Amplification Control Freeze-dried Internal Amplification Control

Package Sizes Cat. No. 34-2025 25 reactions Package Sizes Cat. No. 34-6025 25 reactions Cat. No. 34-2100 100 reactions Cat. No. 34-6100 100 reactions Cat. No. 34-2250 250 reactions Cat. No. 34-6250 250 reactions Primer sets and nucleotides are prepared in aliquots for 25 tests. Primer sets and nucleotides are prepared in aliquots for 25 tests.

Required Consumables qPCR reaction tubes and caps Required Consumables qPCR reaction tubes and caps Optional: For calibration we recommend our Legionella pneumophila PCR Quan- Optional: For calibration we recommend our Pseudomonas aeruginosa PCR Quan- tification Standard (Cat. No. 52-0101). tification Standard (Cat. No. 52-0071).

Required Lab Devices Pipetting equipment Required lab devices Pipetting equipment qPCR cycler with filter sets for FAM™ and ROX™ qPCR cycler with filter sets for FAM™ and ROX™

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re- Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re- hydration the reagents must be stored below -18 °C. hydration the reagents must be stored below -18 °C

Compliance AFNOR XP T90-471 and ISO/TS 12869:2012 Compliance No guidelines are available for molecular testing of Pseudomonas aeruginosa in water samples.

44 45 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

AquaScreen® Escherichia coli

Features

Type of PCR Quantitative real-time PCR (qPCR)

Description The AquaScreen® Escherichia coli qPCR Detection Kit is used for DNA samples prepared with the AquaScreen® FastExtract for quantification of Escherichia coli in waters samples.

Recommended Use / Scope Applicable in research and industry for QA testing of household and process wa- ter. Not recommended for clinical diagnostics, testing of human samples or phar- maceutical products.

Kit Components Freeze-dried primer, probes, nucleotides and polymerase Rehydration Buffer Freeze-dried Positive Control DNA Freeze-dried Internal Amplification Control

Package Sizes Cat. No. 34-7025 25 reactions Cat. No. 34-7100 100 reactions Cat. No. 34-7250 250 reactions Primer sets and nucleotides are prepared in aliquots for 25 tests.

Required Consumables qPCR reaction tubes and caps Optional: For calibration we recommend our Escherichia coli PCR Quantification Standard (Cat. No. 52-0083).

Required Lab Devices Pipetting equipment qPCR cycler with filter sets for FAM™ and ROX™

Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months. After re- hydration the reagents must be stored below -18 °C.

Compliance No guidelines are available for molecular testing of Escherichia coli in water sam- ples.

46 47 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Food Control™ Benefits

Detecting bacterial contamination is a key aspect in food microbiology. Consequently, microbiological Very sensitive quality control programs are intensified throughout food chain production in order to minimize the risk Detection accomplished down to 10 DNA copies/assay. of intoxicating consumers. Reliability, speed and robustness of a test system to detect the presence or absence, or even the degree of contamination with pathogens, becomes increasingly important. Ease of use Isolated total DNA from potentially contaminated food serves as starting material, typically after pre- Food Control™ kit series includes Food Control™ qPCR, Food Control™ LFA and Food Control™ LFA+ cultivation in a suited sample growth medium. Detection is done via qPCR or via conventional PCR plus PCR kits for fast and reliable detection of foodborne pathogens via real-time PCR or via our proprietary Lateral Flow Assay (LFA) technology, making gels unnecessary and if combined with pre-cast hybridiza- Lateral Flow Assay (LFA) technology, respectively. Food Control™ qPCR is a diagnostic system for easy tion cartridges and chamber significantly reduces carry-over. determination of contamination degree in agricultural or food industry via real-time PCR. LFA techno- logy provides stripes as an easy read-out making DNA gels obsolete and in combination with our LFA+ Instrument Compatibility cartridges and pre-cast chambers provide maximum contamination prevention. Food Control™ kits can Food Control™ qPCR works on cyclers with FAM™ and HEX™ filters. be combined with our optimized DNA extraction system ExtractNow™ Food Control. Food Control™ LFA requires any conventional PCR cycler.

One extract – multiple parameters One extract can be used for PCR reactions with different specificities, so that multiple microorganisms can be analyzed in parallel and on users’ choice.

Clear A clear and easily interpretable result is obtained with one PCR reaction. No subsequent and laborious detection or cost-intensive devices are required.

Stable All master mixes are freeze-dried and need to be rehydrated with a supplied buffer to reduce shipping costs and increase product stability.

Contamination prevention All PCR kits can also be used with UNG for carry-over prevention (UNG is not included).

48 49 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

ExtractNow™ Food Control Food Control™ qPCR

Features Features

Description Spin column based DNA extraction method for a broad range of different enrich- Type of PCR Quantitative real-time PCR (qPCR) ment broths as starting material. Using a cutting-edge chemistry, the duration of the DNA purification is reduced to a minimum. Description Taqman® Assay based on FAM and HEX labeled probes. Food Control™ qPCR is a PCR-kit for fast and reliable detection of foodborne pathogens via real-time PCR. Recommended Use / Scope The ExtractNow™ Food Control kit is for research and industrial use only. Not rec- ommended for clinical applications. The kit is used for the extraction of bacte- Recommended Use / Scope Can be used in research and industry for detection of pathogenic contamina- rial DNA only. The kit is not suitable for the extraction of eukaryotic DNA or RNA. tion in food or agricultural products. Do not use for clinical diagnostic or testing of patient samples. Kit Components Spin filter columns, collection tubes, lysis, wash and elution buffers. Kit Components qPCR mix, species mix, rehydration buffer, PCR grade water, internal control, Package Sizes Cat. No. 609-1010 10 extractions positive control Cat. No. 609-1050 50 extractions Package Sizes 25 reactions each: Required Lab Devices Micro centrifuge, rack for 1.5 ml tubes Cat. No. Species Variable microliter pipettes and filter tips 11-02-01-025 11-02-02-025 Shelf Life and Storage Components can be stored room temperature for at least 12 months. 11-02-03-025 Shigella spp. 11-02-04-025 Campylobacter spp. 11-02-05-025 Clostridium perfringens Compliance No, certification in progress 11-02-06-025 Shiga Toxin 1 11-02-07-025 Shiga Toxin 2 11-02-08-025 Escherichia coli O157 11-02-09-025 Escherichia coli O104 11-02-10-025 Listeria spp. 11-02-11-025 Listeria monocytogenes 11-02-12-025 Salmonella spp.

Required Consumables PCR reaction tubes, 1.5 ml reaction tubes Optional: DNA can be extracted from enrichment broth using the DNA extraction kit ExtractNow™ Food Control (Cat. No. 609-1050) or user method.

Required Lab Devices qPCR cycler with FAM™ and HEX™ filter, variable microliter pipettes, benchtop centrifuge for 1.5 ml reaction tubes

Shelf Life and Storage Components can be stored at +2 to +8 °C for at least 12 months. After rehydra- tion the reagents must be stored below -18 °C.

Compliance No, certification in progress

50 51 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Food Control™ LFA Food Control™ LFA+

Features Features

Type of PCR Conventional PCR, LFA Stripe Type of PCR Conventional PCR, LFA Stripe, Hybridization Cartridge Food Control™ LFA is a PCR-kit for fast and reliable detection of foodborne patho- gens via conventional PCR in combination with our reliable Lateral Flow Assay Description Food Control™ PCR-LFA+ is based on the regular Food Control™ PCR-LFA design, (LFA) evaluation technology. but provides additionally a convenient pre-casted hybridization cartridge. This system allows the single-use, cross-contamination safe reading of the PCR re- Description The assay is based on a one tube amplification with a conventional PCR cycler sult for each sample individually. and a subsequent probe specific hybridization technique. The resulting interpre- tation is a simple readout of colored bars on a lateral flow stripe. Recommended Use / Scope Can be used in research and industry for detection of pathogenic contamina- tion in food or agricultural products. Do not use for clinical diagnostic or testing Recommended Use / Scope Can be used in research and industry for detection of pathogenic contamina- of patient samples. tion in food or agricultural products. Do not use for clinical diagnostic or testing of patient samples. Kit Components PCR Mix, rehydration buffer, PCR grade water, positive control, species specific primer, species specific probe, LFA stripe, LFA running buffer, LFA+ cartridge, Kit Components PCR Mix, rehydration buffer, PCR grade water, positive control, species specific LFA cartridge chamber. primer, species specific probe, LFA stripe, LFA running buffer Package Sizes 25 reactions each: Package Sizes 25 reactions each: Cat. No. Species Cat. No. Species Cat. No. Species 11-04-01-025 Salmonella enterica 11-03- 11-03- 11-04-02-025 Yersinia enterocolitica …01-025 Salmonella enterica …07-025 Shiga Toxin 2 11-04-03-025 Shigella spp. …02-025 Yersinia enterocolitica …08-025 Escherichia coli O157 11-04-04-025 Campylobacter spp. …03-025 Shigella spp. …09-025 Escherichia coli O104 11-04-05-025 Clostridium perfringens …04-025 Campylobacter spp. …10-025 Listeria spp. 11-04-06-025 Shiga Toxin 1 …05-025 Clostridium perfringens …11-025 Listeria monocytogenes 11-04-07-025 Shiga Toxin 2 …06-025 Shiga Toxin 1 …12-025 Salmonella spp. 11-04-08-025 Escherichia coli O157 11-04-09-025 Escherichia coli O104 Required Consumables PCR reaction tubes, 2.0 ml reaction tubes 11-04-10-025 Listeria spp. Optional: DNA can be extracted from enrichment broth using the DNA extraction 11-04-11-025 Listeria monocytogenes kit ExtractNow™ Food Control (Cat. No. 609-1050) or user method. 11-04-12-025 Salmonella spp.

Required Lab Devices Racks for reaction tubes, benchtop centrifuge for reaction tubes or PCR plates, Required Consumables 0.2 ml PCR reaction tubes vortex, variable microliter pipettes (1 µl - 1000 µl), sterile filter tips, any conven- Optional: DNA can be extracted from enrichment broth using the DNA extraction tional PCR cycler. kit ExtractNow™ Food Control (Cat. No. 609-1050) or user method.

Shelf Life and Storage Kit components can be stored at +2 to +8 °C for at least 12 months. After rehy- Required Lab Devices Racks for reaction tubes, benchtop centrifuge for reaction tubes or PCR plates, dration the reagents must be stored below -18 °C. vortex, variable microliter pipettes (1 µl - 1000 µl), sterile filter tips, any conven- tional PCR cycler.

Compliance No, certification in progress Shelf Life and Storage Kit components can be stored at +2 to +8 °C for at least 12 months. After rehy- dration the reagents must be stored below -18 °C.

Compliance No, certification in progress

52 53 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

ExtractNow™ Meat ID

Meat ID™ Kits Features Description Spin column based DNA extraction method for a broad range of meat starting Meat ID™ kit series includes Meat ID™ Screen and Meat ID™ Halal, which can be combined with our materials. Using a cutting-edge chemistry, the duration of the DNA purification optimized DNA extraction system ExtractNow™ Meat. The identification of different meats, especially is reduced to a minimum. in minced meat products is a serious task in food safety and from an ethical perspective, especially for Muslims. Authentication of forbidden or none declared ingredients such as pork or substandard meat Recommended Use / Scope The ExtractNow™ Meat ID kit is for research and industrial use only. Not recom- is essential to ensure confidence in the supply chain and regulatory compliance. mended for clinical applications. The kit is used for the extraction of eukaryotic DNA only. The kit is not suitable for the extraction of bacterial DNA or RNA. Meat ID™ Screen introduces our qPCR based screening system for simultaneous detection of the most common meat species, i.e. Goat, Sheep, Pork, Horse, Beef, Donkey, Fish, Chicken, Turkey, Camel, Zebra Kit Components Spin filter columns, collection tubes, lysis, wash and elution buffers. in meat and other foods by qPCR. Meat ID™ Screen is provided as lyophilized mix in PCR stripes, which after rehydration is ready to go for your samples and subsequent qPCR. Meat ID™ Halal is a PCR kit for Package Sizes Cat. No. 608-1010 10 extractions the detection of pork and donkey contamination in meat products and is provided as lyophilized ready Cat. No. 608-1050 50 extractions to use master-mix. Both kits are available for rapid and reliable analysis from various matrices including raw, or even highly processed and cooked meat products where the DNA may be significantly degraded. Required Lab Devices Micro centrifuge, rack for 1.5 ml tubes Variable microliter pipettes and filter tips

Benefits Shelf Life and Storage Components can be stored room temperature for at least 12 months.

Very sensitive Compliance None It is possible to identify relevant species down to a threshold level of 0.5 % with a semi-quantitative result.

Ease of use Sample preparation includes simple DNA extraction (ExtractNow™ Meat ID) prior to direct PCR analysis.

Instrument Compatibility Meat ID™ qPCR works on cyclers with FAM™ and HEX™ filters.

Clear A clear and easily interpretable result is obtained with one PCR reaction. No subsequent and laborious detection or cost-intensive devices are required.

Stable All PCR kits are freeze-dried and need to be rehydrated with a supplied buffer to reduce shipping costs and increase product stability.

Contamination prevention All PCR kits can also be used with UNG for carry-over prevention (UNG is not included).

54 55 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Meat ID™ Screen Meat ID™ Halal

Features Features

Type of PCR Quantitative real-time PCR (qPCR) Type of PCR Quantitative real-time PCR (qPCR)

Description Meat ID™ Screen is a kit for the fast and reliable identification of several animal Description Meat ID™ Halal is a kit for the fast and reliable identification of pork and donkey species (Goat, Sheep, Pork, Horse, Beef, Donkey, Fish, Chicken, Turkey, Camel, contamination in meat and other foods by qPCR. Zebra) in meat and other foods by qPCR in a single parallel run. Meat ID™ Halal is available for rapid and reliable analysis from various matrices Meat ID™ Screen is available for rapid and reliable analysis from various matri- including raw, or even highly processed and cooked meat products where the DNA ces including raw, or even highly processed and cooked meat products where may be significantly degraded. It is possible to identify pork and donkey down to the DNA may be significantly degraded. It is possible to identify relevant species a threshold level of 0.5% with a semi-quantitative result. down to a threshold level of 0.5 % with a semi-quantitative result. Recommended Use / Scope Can be used in research and industry for detection of pork and donkey in meat Recommended Use / Scope Can be used in research and industry for detection (screening) of animal species and other foods by qPCR. For research use only! Do not use for clinical diagnos- (Goat, Sheep, Pork, Horse, Beef, Donkey, Fish, Chicken, Turkey, Camel, Zebra) in tic or testing of patient samples. meat and other foods by qPCR. For research use only! Do not use for clinical di- agnostic or testing of patient samples. Kit Components Primer sets, nucleotides, internal amplification control and polymerase at op- timized concentrations lyophilized in one tube. Rehydration buffer, Lyophilized Kit Components Primer sets, nucleotides, polymerase and internal control DNA, lyophilized, filled positive control, PCR grade water. in 0.2 ml PCR reaction tubes (Stripes). Rehydration buffer, Positive control, PCR grade water. Package Sizes Cat. No. 12-02-025 25 tests Cat. No. 12-02-100 100 tests Package Sizes Cat. No. 12-01-005 5 tests Cat. No. 12-01-020 20 tests Required Consumables PCR reaction tubes, 1.5 ml reaction tubes, pipette tips Cat. No. 12-01-040 40 tests Optional: DNA can be extracted from sample material using DNA extraction kits Required Consumables Pipette tips e.g. ExtractNow™ Meat (Cat. No. 608-1050) or user method.

Optional: DNA can be extracted from sample material using DNA extraction kits Required Lab Devices qPCR cycler with FAM™ and HEX™ filter. Variable microliter pipettes benchtop e.g. ExtractNow™ Meat (Cat. No. 608-1050) or user method. centrifuge for 1.5 and 0.2 ml reaction tubes

Required Lab Devices qPCR cycler with FAM™ and HEX™ filter. Variable microliter pipettes benchtop Shelf Life and Storage Kit components can be stored at +2 to +8 °C for at least 12 months. After rehy- centrifuge for 1.5 and 0.2 ml reaction tubes dration the reagents must be stored below -18 °C.

Shelf Life and Storage Kit components can be stored at +2 to +8 °C for at least 12 months. After re- Compliance Halal ethical guidelines hydration of the individual PCR tubes the reagents must be used within 1 hour.

Compliance No guidelines are available for molecular testing of meat contamination in meat samples.

56 57 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

ExtractNow™ Vegan Control

Vegan Control™ Kits Features Description Manual magnetic bead based DNA extraction method for a broad range of food Vegan Control™ kit series includes Vegan Control™ OneStep and Vegan Control™ Advance, and can be starting materials. Using a cutting-edge chemistry, the duration of the DNA puri- combined with our optimized DNA extraction system ExtractNow™ Vegan Control. Vegan Control™ One- fication is reduced to a minimum. Step is a ready-to-use lyophilized master mix in a tube while Vegan Control™ Advance is pre-aliquoted and lyophilized in high profile stripes ready for your samples upon rehydration with buffer. Recommended Use / Scope The ExtractNow™ Food kit is for research use only. Not recommended for clini- cal applications The population number of vegetarians and people following the vegan lifestyle increase from year to year. This may be due to ethical, religious, cultural or health reasons. How do you ensure that your ve- Kit Components Magnetic beads, tubes, lysis, wash and elution buffers. gan sausage has really been processed without meat and animal derived products? We offer a quick and inexpensive solution. The solution is Vegan Control™, a qPCR based System for the detection of Package Sizes Cat. No. 607-1010 10 extractions animal traces in food. Cat. No. 607-1050 50 extractions

Required Lab Devices Magnetic rack for 1.5 ml tubes (e.g. Cat. No. 607-0001), variable microliter pipet- Benefits tes and filter tips

Very sensitive Shelf Life and Storage Components can be stored room temperature for at least 12 months. It is possible to identify relevant species down to a threshold level of 0.05 % with a semi-quantitative result. Compliance None Ease of use Sample preparation includes simple DNA extraction (ExtractNow™ Vegan Control kit) prior to direct PCR analysis.

Instrument Compatibility Vegan Control™ qPCR works on cyclers with FAM™ and HEX™ filters.

Clear A clear and easily interpretable result is obtained with one PCR reaction. No subsequent and laborious detection or cost-intensive devices are required.

Stable All PCR kits are freeze-dried and need to be rehydrated with a supplied buffer to reduce shipping costs and increase product stability.

Contamination prevention All PCR kits can also be used with UNG for carry-over prevention (UNG is not included).

58 59 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Vegan Control™ OneStep Vegan Control™ Advance

Features Features

Type of PCR Quantitative real-time PCR (qPCR) Type of PCR Quantitative real-time PCR (qPCR)

Description Vegan Control™ OneStep is a qPCR based system for the detection of animal Description Vegan Control™ Advance contains PCR reaction tubes pre-coated with all PCR traces in food provided as a lyophilized one tube master mix. reagents to reduce the total assay time without need to prepare aliquots of a master mix. Recommended Use / Scope Can be used in research and industry for detection of meat/animal based con- tamination of vegan foods. For research use only! Do not use for clinical diagnos- Recommended Use / Scope Can be used in research and industry for detection of meat/animal based con- tic or testing of patient samples. tamination of vegan foods. For research use only! Do not use for clinical diagnos- tic or testing of patient samples. Kit Components Primer sets, nucleotides, internal amplification control and polymerase at opti- mized concentrations lyophilized in one tube, rehydration buffer, lyophilized po- Kit Components Primer sets, nucleotides, polymerase and internal control DNA, lyophilized, filled sitive control, PCR grade water. in 0.2 ml PCR reaction tubes, rehydration buffer, lyophilized positive control, PCR grade water. Package Sizes Cat. No. 12-05-025 25 tests Cat. No. 12-05-100 100 tests Package Sizes Cat. No. 12-06-024 24 tests Cat. No. 12-06-096 96 tests Required Consumables PCR reaction tubes, 1.5 ml reaction tubes, Pipette Tips Cat. No. 12-06-240 240 tests Optional: DNA can be extracted from sample material using DNA extraction kits e.g. ExtractNow™ Vegan (Art.-Nr. 607-1050) or user method. Required Consumables PCR reaction tubes, 1.5 ml reaction tubes, Pipette Tips Optional: DNA can be extracted from sample material using DNA extraction kits Required Lab Devices qPCR cycler with FAM™ and HEX™ filter. Variable microliter pipettes benchtop e.g. ExtractNow™ Vegan (Cat. No. 607-1050) or user method. centrifuge for 1.5 and 0.2 ml reaction tubes. Required Lab Devices qPCR cycler with FAM™ and HEX™ filter. Variable microliter pipettes benchtop Shelf Life and Storage Kit components can be stored at +2 to +8 °C for at least 12 months. After rehy- centrifuge for 1.5 and 0.2 ml reaction tubes dration the reagents must be stored below -18 °C. Shelf Life and Storage Components can be stored at +2 to +8 °C for at least 12 months. After rehydra- Compliance No guidelines are available for molecular testing of animal traces in vegan food. tion the reagents must be stored below -18 °C.

Compliance No guidelines are available for molecular testing of animal traces in vegan food.

60 61 Nucleic Acid Extraction

62 63 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

ExtractNow™ Plasmid Mini Kit ExtractNow™ DNA Mini Kit

Features Features

Description Easy and quick plasmid isolation from bacterial lysis. Description Universally applicable DNA extraction method for a broad range of starting ma- terials. Type of Sample Bacterial suspensions Using a cutting-edge chemistry, the duration of the DNA purification is reduced Isolation of high-copy plasmids: 0.5 – 5 ml to a minimum. Isolation of low-copy plasmid DNA, P1 constructions, etc.: > 5 - 10 ml

Type of Sample Tissue samples of up to 50 mg Separation principle Spin filter columns Rodent tail specimens 0.5 – 1 cm in length Paraffin samples (tissue) The ExtractNow™ Plasmid Mini Kit is for research use only. Not recommended Recommended Use / Scope 6 for clinical applications. Eucaryotic cells (max. 5 × 10 ) Buccal swabs

Package Sizes Cat. No. 605-1010 10 extractions Cat. No. 605-1050 50 extractions Separation principle Spin filter columns

Shelf Life and Storage Components are maintainable at room temperature for at least 6 months. Recommended Use / Scope The ExtractNow™ DNA Mini kit is for research use only. Not recommended for clinical applications Specifications Time of Extraction: Approx. 16 minutes Binding capacity: Column binding capacity: approx. 40 μg pDNA Package Sizes Cat. No. 601-1010 10 extractions Average yield: Typical yield from 2 ml starting material (highcopy plasmid) 6 - 20 μg Average purity: 1.8 - 2.0 Cat. No. 601-1050 50 extractions

Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months. Store the lyophilized Proteinase K at +2 to +8 °C

Specifications Time for extraction: Approx. 8 minutes after lysis Binding capacity: > 100 μg gDNA Average yield: Up to 65 μg (depends on the type and quantity of the sample material) Average purity: 1.7 – 2.0

64 65 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

ExtractNow™ Blood DNA Mini Kit ExtractNow™ RNA Mini Kit

Features Features

Description Direct and rapid isolation of genomic DNA from whole blood up to 400 μl. High Description Purification of total RNA from eukaryotic and microbial materials. Prefiltration to yields of up to 30 mg and extremely high-quality gDNA, depending on the sample selectively remove genomic DNA with no DNase digestion. and the amount used. There are two protocols available: < 200 µl and up to 400 µl blood samples. Type of Sample Eucaryotic cells (max. 5 × 106) Tested for EDTA and citrate stabilized and for fresh or frozen blood sample Tissue samples (max. 20 mg) (including long time storage). Gram+ and gram– bacteria (max. 1 × 109) Biopsies Type of Sample Whole blood samples (up to 400 μl) Fresh or frozen blood Separation principle Spin filter columns Stabilizers: EDTA or citrate

Recommended Use / Scope The ExtractNow™ RNA Mini Kit is for research use only. Separation principle Spin filter columns Not recommended for clinical applications.

Recommended Use / Scope The ExtractNow™ Blood DNA Mini kit is for research use only. Not recommended Package Sizes Cat. No. 603-1010 10 extractions for clinical applications Cat. No. 603-1050 50 extractions

Package Sizes Cat. No. 602-1010 10 extractions Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months. Cat. No. 602-1050 50 extractions

Specifications Time for Extraction: Approx. 15 – 40 minutes Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months. Binding capacity: approx. 100 μg RNA Store the lyophilized Proteinase K at +2 to +8 °C Average yield: Depends on the type and quantity of the starting material up to 100 μg RNA Specifications Time for Extraction: Approx. 24 minutes, including lysis Average purity: 1.8 – 2.1 Binding capacity: > 50 μg gDNA Average yield: Up to 30 μg gDNA (depends on the type and quantity of the sample material) Average purity: 1.7 – 2.0

66 67 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

ExtractNow™ CleanUp Kit ExtractNow™ Virus DNA/RNA Kit

Features Features

Description Combination kit for fast extraction of DNA fragments from agarose gels or Description Simultaneous isolation of viral DNA and RNA from a variety of starting materials. amplification products from PCR reaction mixtures. Flexible elution volumes Extraction method based on the use of Spin Filters. Optimum removal of between 30 and 50 μl and 10 to 20 μl. High recovery rates of up to 95 %. Capable inhibitors ensures trouble-free use of nucleic acids in subsequent applications. of processing fragment lengths of up to 30 kb. Recommended for samples with unknown viruses. Includes Carrier Mix.

Type of Sample PCR reaction mixes (up to 50 μl) Type of Sample Serum, plasma, cell-free bodily fluids, supernatants from cell cultures (400 μl TAE agarose gels (up to 300 mg) each) TBE agarose gels (up to 300 mg) Tissues and biopsies of up to 20 mg Swab samples Separation principle Spin filter columns Separation principle Spin filter columns Recommended Use / Scope The ExtractNow™ CleanUp Kit is for research use only. Not recommended for clinical applications. Recommended Use / Scope ExtractNow™ Virus DNA/RNA Kit is for research use only. Not recommended for clinical applications. Package Sizes Cat. No. 604-1010 10 extractions Cat. No. 604-1050 50 extractions Package Sizes Cat. No. 606-1010 10 extractions Cat. No. 606-1050 50 extractions Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months. Shelf Life and Storage Kit components are maintainable at room temperature for at least 6 months. Specifications Time for Extraction: PCR purification: approx. 3 minutes (2-step process) Store the lyophilized Proteinase K at +2 to +8 °C Gel extraction: approx. 20 minutes Store the lyophilized Carrier Reagent below -18 °C Binding capacity: > 20 μg DNA Fragment lengths: PCR purification: > 60 bp – 30 kb Specifications Time of Extraction Approx: 25 minutes Gel extraction: 100 bp – 30 kb Quality: Positive PCR and real-time PCR testing results Average rate of recovery depending on fragment length: PCR purification: approx. 60 % to 95 % Gel extraction: approx. 60 % to 90 %

68 69 DNA Standards and Cleaning

70 71 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Specifity Standards Genomic DNA Extracts

Features Available Strains

Description These preparations contain genomic DNA extracted from low passage and defined Cat. No. Cat. No. microorganisms, prepared by phenol/chloroform extraction and subsequent column absorption methods. The DNA extract was partially sequenced to confirm 51-0116 Acholeplasma laidlawii 51-1515 Legionella pneumophila identity. Titration was done by optical density measurement against a weight calf 2127-30007 Acinetobacter bamanii subsp. pascullei thymus DNA standard. 2128-30187 51-3361 Methicilin-resistant 2101-00819 Aspergillus fumigatus Staphylococcus aureus (MRSA) Recommended Use / Scope Genomic DNA extracts are required for specificity testing of new assays. Genomic 51-0031 Bacillus cereus 2134-30164 Morganella morganii DNA extracts are intended for research use only. Not recommended for clinical 51-0010 Bacillus subtilis 51-0030 Micrococcus luteus diagnostics or testing of human samples. 2129-02046 Bacillus thueringiensis 51-0129 Mycoplasma arginini 51-3415 51-0162 Mycoplasma arthritidis 51-5571 51-0117 Mycoplasma fermentans Kit Components 1 vial of genomic DNA extract, containing 10 ng +/- 2 ng DNA, freeze-dried 2130-07288 Burkholderia capacia 51-0115 Mycoplasma gallisepticum 1 vial 10 mM Tris pH 8.5 2102-04688 51-0195 Mycoplasma genitalium 51-1386 Candida albicans 51-0111 Mycoplasma hominis Shelf Life and Storage Stored at +2 to +8 °C for at least 12 months. After rehydration the reagents must 2103-11226 Candida glabrata 51-0130 Mycoplasma hyorhinis be stored below -18 °C. 2104-11947 Candida guiliermondii 51-0112 Mycoplasma orale 2105-70624 Candida haemulonii 51-1746 Mycoplasma penetrans 2106-30039 51-0119 Mycoplasma pneumoniae 2125-90874 Candida tropicalis 51-0113 Mycoplasma salivarium 2107-04595 51-0124 Mycoplasma synoviae 51-0792 Clostridium acetobutylicum 2135-10036 2108-00756 Clostridium perfringens 2136-13387 51-0053 Enterobacter aerogenes 51-4479 Proteus mirabilis 2110-30054 51-0071 Pseudomonas aeruginosa 2111-20680 Enterococcus casseliflavus 51-7058 Salmonella enterica 2112-30633 Enterococcus durans 2117-30121 51-0478 Enterococcus faecalis 2137-04782 2113-20477 Enterococcus faecium 2138-05570 2114-20160 Enterococcus hirse 51-0164 Spiroplasma citri 51-0083 Escherichia coli 51-0231 Staphylococcus aureus 2115-08579 Escherichia coli 0157:H7 51-0044 Staphylococcus epidermidis 51-1368 Fluoribacter bozemanae 2118-20328 Staphylococcus hominis (syn. Legionella bozemanae) 2119-20263 Staphylococcus haemolyticus 2131-05934 Geobacillus stearothermophilus 2122-20480 Streptococcus bovis 2132-30104 2123-06176 Streptococcus dysgalactiae 2133-70603 Klebsiella pneumoniae, ESBL+ 2126-20523 Streptococcus mutans 51-1723 Lactobacillus acidophilus 51-0566 Streptococcus pneumoniae 51-1370 Legionella dumofii 2139-20068 Streptococcus sanguinis 51-1533 Legionella jordanis 2120-20229 Staphylococcus saprophyticus 51-0101 Legionella pneumophila 2121-50170 Stenotrophomonas maltophilia 51-1514 Legionella pneumophila 51-0177 Ureaplasma urealyticum subsp. fraseri 2140-04780 Yersinia enterocolitica 2141-08992 Yersinia pseudotuberculosis

72 73 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

PCR Quantification Standards

Features Features

Description Standardization and quantification of nucleic acid detection is a difficult task Available Strains Cat. No. 52-0116 Acholeplasma laidlawii as there are no reliable standards for low nucleic acid copy numbers. Detection Cat. No. 52-5571 Bordetella pertussis methods such as PCR and NASBA are prone to inhibition caused by many Cat. No. 52-0101 Legionella pneumophila substances commonly found in plant and animal tissues, food matrices and Cat. No. 52-0129 Mycoplasma arginini extraction solutions. When co-purified with DNA or RNA, inhibitors reduce Cat. No. 52-0117 Mycoplasma fermentans amplification efficiency, causing an underestimation of the quantity of target Cat. No. 52-0115 Mycoplasma gallisepticum nucleic acid or even false-negative results. Cat. No. 52-0130 Mycoplasma hyorhinis Cat. No. 52-0112 Mycoplasma orale Minerva Biolabs calibration reagents contain genomic DNA extracted from low Cat. No. 52-0119 Mycoplasma pneumoniae passage and defined microorganisms. The DNA is manufactured by means of Cat. No. 52-0124 Mycoplasma synoviae phenol/chloroform extraction with ethanol precipitation and subsequent column Cat. No. 52-0164 Spiroplasma citri absorption methods. The DNA extract was partially sequenced and the sequence Cat. No. 52-0071 Pseudomonas aeruginosa aligned to confirm identity. Titration was done after photometric quantification Cat. No. 52-0083 Escherichia coli of the preparation standard and dsDNA fluorometric quantification against a synthetic standard. Shelf Life and Storage Stored at +2 to +8 °C for at least 12 months. After rehydration the reagents must be stored below -18 °C. For the first time, qPCR user are able to include a precise low count of DNA copies in their assays, providing them with a true value for the estimation of detection limits and the comparison of different detection methods.

Recommended Use / Scope These PCR Calibration reagents with a defined concentration of genome copies are used as calibrators to generate standard curves for quantification of target loads with the qPCR technology. In addition, the standards are suitable for specificity testing of assays and sensitivity testing of procedures during quality assurance (QA) validation, especially in correspondence with EP 2.6.7.

Kit Components 1 vial (green cap) of PCR Quantification Standard contains 108 genomes, freeze- dried 3 vials (white cap) with 2 ml of Tris buffer, 10 mM, pH 8.5

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10CFU™ Mycoplasma Sensitivity Standards

Features Features

Description European Pharmacopoeia 2.6.7 Mycoplasmas requires a sensitivity of 10 CFU/ml Selection Cat. No. 102-1003 Mycoplasma arginini sample volume for NAT-based methods like PCR to replace the traditional culture Cat. No. 102-2003 Mycoplasma orale method. This feature of the test method must be shown by the performing lab Cat. No. 102-3003 Mycoplasma gallisepticum as part of the robustness testing in presence of the sample matrix. As most cell Cat. No. 102-4003 Mycoplasma pneumoniae culture labs and production facilities cannot accept vital mycoplasma in their Cat. No. 102-5003 Mycoplasma synoviae facility or do not have access to a microbiology lab able to cultivate mycoplasma, Cat. No. 102-6003 Mycoplasma fermentans 10CFU™ Mycoplasma Sensitivity Standards allow safe and reliable validation of Cat. No. 102-7003 Mycoplasma hyorhinis the procedure. Cat. No. 102-8003 Acholeplasma laidlawii Cat. No. 102-9003 Spiroplasma citri The mycoplasma have been cultivated in culture broth as described in EP 2.6.7, Cat. No. 102-0002 Mycoplasma Set, all EP 2.6.7 listed species titrated immediately in culture broth and plated for quantification in colony forming units (CFU/ml). Each dilution series has been performed in multiple by Result Evaluation Use of a suitable Mycoplasma PCR kit, different operators for highest precision. The mycoplasma broth was harvested in e.g. Venor®GeM Classic (see page 13) or Venor®GeM qEP (see page 16) the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles and correspondingly a high GU:CFU ratio. All strains have been obtained from official culture collections and cultivated in low passages. Required Consumables None

Recommended Use / Scope For validating the robustness and sensitivity of NAT-based mycoplasma test Required Lab Devices Regular lab equipment (centrifuge, pipettes, etc.) methods in presence of the sample matrix. Each vial contains 10 CFU of inactivated mycoplasma. By adding the sample Shelf Life and Storage Kit components are maintainable at +2 to +8 °C for at least 12 months matrix of interest, a sample according to EP 2.6.7 is prepared which has to be tested positive by the method applied. Obviously, the inactivated sample material is not suitable for the culture method anymore. As a result of proficiency tests on NAT-methods for mycoplasma detection it became obvious that in means of highest sensitivity DNA extraction is indispensible. The extract can directly be used for PCR.

Kit Components 3 vials with 10 CFU of the corresponding mycoplasma species 2 negative control vials

For the mycoplasma set: 2 vials with 10 CFU of each mycoplasma species listed in the EP 2.6.7 2 negative controls

1 x positive control

6 x 10 CFU

Fig. 10 CFU have been resuspended in cell culture medium, 200 µl DNA extracted with the Venor®GeM Sample Preparation 2 x negative control Kit and mycoplasmal DNA amplified with Venor®GeM qEP. PCR was performed on a MxPro – Mx3005P®.

76 77 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Cleaning PCR Clean™ Decontamination Spray for the Removal of DNA, RNA, DNases, RNases Contaminations affect various levels of your laboratory routine e.g. by introduction of microbial conta- mination on laboratory surfaces, water baths or incubators or can be acquired at the analytical level through carry over or by trace amounts of target molecules. This poses a significant problem especially Features in the area of highly sensitive PCR or analytical procedures where trace amounts of contaminating mo- Description Contaminant DNA is especially problematic in the highly sensitive PCR technique, lecules can result in inaccurate data or experimental artifacts. as its removal has proven to be no trivial matter. Originating from aerosolized fragments, contaminant DNA can lead to cross contamination between samples We offer our highly effective decontamination products WaterShield™, Lab Clean™, PCR Clean™ and thus resulting in inaccurate data or PCR artefacts. Even a single DNA molecule PCR Clean™ Wipes in order to help you to protect your research. Watershield™ is a disinfection additive can be detected in the amplification process leading to widespread problems for incubators and water baths and is active against a broad range of typical water contaminations from throughout the testing procedure. bacteria, mycoplasma, protozoan, algae, fungi and yeast. Water exchange is conveniently indicated by a diminishing blue stain. Lab Clean™ is a large area decontamination solution useful for floors preven- PCR Clean™ is a ready-to-use solution for eliminating DNA, RNA, DNases and ting room-to-room spreading of e.g. DNA carry over or trace amounts of DNA, keeping your lab “DNA- RNases from any surface. They are completely destroyed and removed within seconds. The solution contains a surfactant and a non-alkaline and non- load” low if regularly applied. Finally, protect your PCR experiments from e.g. carry over or DNases and carcinogenic nucleic acid and protein destroying agent. PCR Clean™ is intended RNases using PCR Clean™ or PCR Clean™ Wipes highly effective surface decontamination reagents. for use at PCR workstations, lab devices, pipettors, etc.

Benefits Highly effective PCR Clean™ is effective against amplicon, plasmid, or genomic DNA and RNA as well as proteins on most surfaces with the exception of light or non-ferrous metals. Convenient and ready-to-use PCR Clean™ is ready-to-use, provided in a spray bottle for the efficient treatment of work spaces. Fast and easy decontamination The use of PCR Clean™ both before and after PCR analysis is fast, easy and ideal to maintain a clean work area and thereby saves time and expenses. Stable PCR Clean™ is heat resistant and stable for several years

Recommended Use / Scope None

Kit Components Ready-to-use formulation in a spray bottle or refill bottles.

Package Sizes Cat. No. 15-2025 250 ml Cat. No. 15-2200 4 x 500 ml Cat. No. 15-2500 5 l

Required Consumables Paper towels

Required Lab Devices None

Shelf Life and Storage Stable at room temperature for at least 12 months.

78 79 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

PCR Clean™ Wipes Lab Clean™ Decontamination Wipes Molecular Microbiology Lab Cleaner for the Removal of DNA, RNA, DNases, RNases

Features Features

Description PCR Clean™ Wipes are the simple solution for cleaning and removal of DNA, Description DNA contaminations are notoriously difficult to remove and can be easily RNA, DNases and RNases from a variety of laboratory surfaces at the same spread via spills especially in connected laboratory areas via the room floor time. There’s no need for multiple products when you have the convenience of a and/or dispersed dust. Keeping room “DNA-load” low is helping to prevent cross simple-to-use wipe. When you use a sponge or even paper towel, you can spread contamination or PCR artefacts in DNA sensitive environments where even a nucleic acids and proteins from one surface to another. Instead of degrading single DNA molecule can be detected in the amplification process leading these contaminants, you are pushing them around and potentially increasing to widespread problems throughout the testing procedure (e.g. PCR, qPCR, the contaminated surface area. sequencing).

Benefits Broad Applicability Lab Clean™ is a DNA decontamination solution available as a concentrate for PCR Clean™ Wipes can be used on hard, nonporous surfaces in every room of the routine laboratory cleaning to eliminate DNA from large areas like room floors and lab including PCR cabinets, pipettes, lab equipment exterior (like PCR cycler, vortexer, is based on a non-carcinogenic DNA destroying chemistry. centrifuges, pipetting robots) and many more. Non-corrosive and non-carcinogenic Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical PCR Clean™ Wipes are made with a bleach- and odor-free formula, composed applications. of the powerful combination of a surfactant and a DNA-destroying agent. PCR Clean™ Wipes are ready-to-use for degrading DNA, RNA, DNases and RNases Kit Components Easy applicable 200x aqueous solution. from surfaces like glass, ceramic, plastic, rubber, steel and precious metal. They can be used as a routine contamination control program in your PCR laboratory. Package Sizes Cat. No. 15-4100 1 l bottle Broad inactivation range PCR Clean™ Wipes degrade DNA, RNA, DNases and RNases within seconds. Required Consumables None Easy to use It’s simple. Wipe surface clean with PCR Clean™ Wipes. Let it air-dry. Convenient where Required Lab Devices None spraying is not applicable (e.g. covers of electronic devices, electronic pipettes). Shelf Life and Storage Stored at room temperature. Stable for at least 12 months. Recommended Use / Scope Applicable in research and industry, only. Not recommended for clinical applications. Use as directed. Always test a small area first for stability and coloration. PCR Clean™ Wipes should not be used for the cleaning of light or non-ferrous metals.

Kit Components Single use wipes in a product safety sachet.

Package Sizes Cat. No. 15-2001 120 wipes in a dispenser box Cat. No. 15-2002 5x120 refill sachets

Required Consumables None

Required Lab Devices None

Shelf Life and Storage Shipped and storage at room temperature. Stable for at least 12 months.

80 81 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

WaterShield™ Water Disinfection Additive

Features

Description Water required for CO2 incubators is preset to microbial contamination due to ideal environmental conditions. WaterShield™ protects the water in the reservoir from microbial growth.

Benefits Broad Applicability WaterShield™ can also be used in regular water/heating baths and is compatible with common work surfaces (e.g. tin plated iron, chrome, nickel steel, high grade steel and copper). No cell toxicity Thewater additive contains quaternary ammonium compounds and surfactants as disinfecting and cleaning ingredients, but no aldehydes, phenols, alcohols or azides. These reagents are not vaporizing and are therefore safe to the cells. All ingredients are safe to humans and do not cause any irritating effects to the skin when used in the recommended concentration. No odor annoyance is noticeable. Broad inactivation range WaterShield™ is active against most bacteria, mycoplasma, protozoa, algae, fungi and yeast. Easy to use Simply add one bottle (5 ml) of WaterShield™ directly to one liter of deionized water. Stability The reagent is usually active for 4 weeks. A blue stain indicated the status of the additive. In case of increasing bioburden a renewal of the water and the additive is required.

Recommended Use / Scope Applicable in research and industry only. Not recommended for clinical applications. Do not use with acrylic glass or aluminum surfaces.

Kit Components Easy applicable 200x aqueous solution.

Package Sizes Cat. No. 15-3015 30x 5 ml Cat. No. 15-3020 3x 50 ml Cat. No. 15-3050 500 ml

Result Evaluation Color change

Required Consumables None

Required Lab Devices None

Shelf Life and Storage Shipped and storage at room temperature. Stable for at least 12 months.

82 83 Contract Manufacturing

84 85 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Introduction Liquid Handling Minerva Biolabs is a contract manufacturer specialised in the design and production of molecular bio- logical reagents, PCR assays and sample preparation kits. Our service portfolio also includes any kind of liquid handling from litre to microlitre. We use auto- mated and semi-automated devices to guarantee highest and consistent accuracy. Our liquid han- With our flexibility and experience as contract manufacturer of complex assays and kits for various dling service includes aqueous (low to moderate viscosity) and alcoholic solutions from small to notable customers, we are an ideal partner for you and your product. We will reliably handle small to large batch sizes. large batch sizes according to your needs.

As a contract manufacturer, we offer our service and experience of more than 15 years in producing various molecular biological reagents and kits. Our special asset is to manufacture lyophilized molecu- Quality Control lar biological components and PCR kits, including in vitro diagnostics. In addition, we will help you to make your product successfully marketable. Minerva Biolabs’ analytical services include incoming goods inspection, in-process controls as well as product release testing. We are certified according to iSO 13485 with a proven record as contract manufacturer serving cus- tomers around the world. In our production facilities, we handle chemicals as well as biotechnologi- We perform HPLC analysis, UV and iR-Spectroscopy, microbiological batch monitoring and qPCR anal- cally produced substances, e.g. enzymes, peptides, proteins, polysaccharides, hormones, vaccines ysis. With our GMP-certified partner Minerva Analytix GmbH, we are able to perform further methods and homeopathic drugs. and analyses to meet your requirements.

Product Design Packaging

The design is the key to success for any product. Various aspects need to be considered when an idea, Our packaging team offers various options ranging from bulk to final packaging to meet your individual an assay or even an existing product is transformed into a marketable and successful product. expectations and requirements. We even organise the purchasing, storage and logistics of your pack- ing materials if desired. We offer our service for the entire design process from assay optimization and composition to kit development and final product appearance. Our team of product development specialists, graphic designers, manufacturing professionals as well as market and logistics experts is looking forward to assist you. Logistics

As an established contract manufacturer with a proven record of success, we will tailor your product to We offer traceable raw material supply for product shipment including purchasing, storage, and in- meet your expectations as well as your customers’ including regulatory requirements. coming goods inspection.

As part of our clinical trial service we provide small batches of APi’s or diagnostic products but also randomized packaging according to individual requirements and shipping to Lyophilization clinical trial sites.

Minerva Biolabs operates state-of-the art freeze-dryers with capacities from 100 to 10,000 vials per We will store your product at defined conditions, constantly monitored, and ship your products to day providing highest flexibility for any batch size. Our lyophilization service is compatible with various destinations around the world, even anonymously under your company ID. We organise any shipment formats such as PCR tubes, 96-well microtiter plates, microfluidic disks and microtubes. including dry ice shipments to your customers or distributors.

We will establish the lyophilization process for your product components including process engineering.

As an innovative manufacturer, we perform research projects facilitated by public funding to further develop our expertise in the lyophilisation of molecular biological reagents and mixes for PCR, qPCR, and RT-PCR.

86 87 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Appendix

Licenses & Trademark Information Terms and Conditions

Limited Product Warranty By ordering a product hereunder, the customer accepts these terms and conditions. The terms and This warranty limits our liability for replacement of this product. No warranties of any kind, express or conditions may be subject to change at any time and it is the customer’s responsibility to check the terms implied, including, without limitation, implied warranties of merchantability or fitness for a particular and conditions prior to ordering such products for any amendments and/or alterations. Unless otherwise purpose, are provided. Minerva Biolabs shall have no liability for any direct, indirect, consequential, specifically agreed in writing by the Minerva Biolabs GmbH these conditions shall govern all contracts or incidential damages arising out of the use, the results of use, or the inability to use this product. between the Minerva Biolabs GmbH and the customer for the sale of any of the products and shall prevail over any conditions or terms stipulated, referred to or incorporated by the customer in its or- Trademarks der or negotiations. Venor, Onar, AquaScreen, Mynox, and ZellShield are registered trademarks of Minerva Biolabs GmbH. 10CFU, Mycoplasma Off, Watershield, PCR Clean, Lab Clean, Vegan Control, Meat ID, and ExtractNow Placing of Orders are trademarks of Minerva Biolabs GmbH. VIC, Texas Red, and SYBR are registered trademarks and All orders placed by a customer shall be subject to the product availability and the written acceptance HEX, JOE, ROX, and TAMRA are trademarks of Applera Corp. or its subsidiaries in the US and/or certain of the Minerva Biolabs GmbH. The Minerva Biolabs GmbH shall confirm acceptance of the order in wri- other countries. SYBR and Texas Red are registered trademarks of Molecular Probes, Inc. Cy 3 and Cy ting, sending the product and invoice or by e-mail. 5 are trademarks of GE Healthcare. The customer shall submit its full company name, address, telephone and fax numbers and custo- LightCycler is a registered trademark of a member of the Roche Group. ABI Prism is a registered trade- mer number (if applicable) to the Minerva Biolabs GmbH. mark of Applera Corporation or its subsidiaries in the US and certain other countries. Mx3005P is a reg- istered trademark of Agilent Technologies. RotorGene is a registered trademark of Corbett Life Science. Payment and Delivery The Minerva Biolabs GmbH will use its reasonable endeavours to deliver the products to the customer Limited License - Mynox® / Mynox®Gold as soon as practicable and in general within 1-3 days of the date of order acceptance. For the avoi- The purchase price of this product includes a limited, non-transferable license under German Patent 195 dance of doubt, the Minerva Biolabs GmbH will not be in breach of these conditions or have any liability 21 938 or its foreign counterpart, owned by Minerva Biolabs GmbH, to use only this amount of the prod- whatsoever for failing to deliver the products to the customer by this date. Partial deliveries are permit- uct to practice the Mynox® technique. No right to perform or offer commercial services of any kind using ted, any delivery is an autonomous business. Unless otherwise agreed in writing by the Minerva Biolabs Mynox® is hereby granted by implication or estoppel. Further information on purchasing licenses may GmbH, payment of the full price (including any VAT) and any additional costs (including but not limited to be obtained by contacting Minerva Biolabs GmbH, Koepenicker Strasse 325, 12555 Berlin, Germany. postage /packaging/carraige costs) will be made by the customer in full before delivery shall be effected. The Customer hereby agrees to effect payment to Minerva Biolabs GmbH by way of bank draft or cheque or credit card.

Price The prices of the products shall be as set out in the Price List and are correct at the time of entering the information. However, the Minerva Biolabs GmbH reserves the right to change the price without prior noti- ce. All Prices quoted are in Euro or US$ as indicated in the Prise List / Invoice. All Prices quoted are exclu- sive of VAT and all other duties, taxes or charges which the customer shall pay in addition to the price.

Cancellation Whilst every effort will be made to meet the customer’s individual requirements, the Minerva Biolabs GmbH shall be under no obligation to accept amendments or cancellation of any order or any part thereof. If cancellation is accepted by the Minerva Biolabs GmbH, any costs or expenses incurred by the Minerva Biolabs GmbH up to the date of cancellation and all loss or damage resulting from the cancellation will be paid by the customer. The Minerva Biolabs GmbH shall be entitled to cancel any contract(s) with the customer (subject to refunding the price previously paid by the customer) without penalty at any time by giving written notice to the customer.

Use of Product The product information sheet (“Product Information Sheet”) delivered with the products sets out the Company’s recommended use and storage of the products. The information contained in the Product

88 89 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Information Sheet is for informational purposes only and should not be relied upon. The Minerva Biolabs The Minerva Biolabs GmbH shall be responsible for adherence to German laws and regulations insofar GmbH accepts no responsibility for and excludes all liability for damage and loss in connection with the as products manufactured in Germany are exported. The observance and implementation of laws and use of the product and/or the information contained in the Product Information Sheet. Whilst the Minerva regulations applying outside Germany shall be the exclusive responsibility of the customer. If any provi- Biolabs GmbH believes the information to be true and accurate at the date of writing the Minerva Biolabs sion of these Conditions is held by any competent authority to be invalid or unenforceable in whole or GmbH can give no assurances or warranty regarding the accuracy, currency or applicability of any of the in part, the validity of the remaining conditions shall not be affected. Failure or omission by the Minerva information in relation to specific situations or particular circumstances. Although every care is taken by Biolabs GmbH to enforce strict compliance with these Conditions by the customer shall not constitute a the Company in responding to requests for information and advice by telephone, facsimile, and e-mail no waiver of any of these Conditions. Notices must be in writing to the Minerva Biolabs’ or the customer’s liability is accepted by the Minerva Biolabs GmbH where information relating to the customer’s order address and shall be deemed delivered on the first working day after sending by hand or (subject to is distorted in transmission. Any claim by the customer which is based on any non-performance of the confirmation of the transmission) by telex or facsimile or, on the third working day after being placed products shall be notified to the Minerva Biolabs GmbH in writing within 30 days from the date of deli- prepaid in the first class post to the Minerva Biolabs’ or the customer’s address. very of the Products. If the customer omits to notify the Minerva Biolabs GmbH in accordance with this Condition the Minerva Biolabs GmbH shall have no liability for such non-performance. Minerva Biolabs GmbH, Berlin 01.2016

Liability Not with standing anything in these Conditions to the contrary and save for the liability of the Minerva Biolabs GmbH for death and personal injury caused by its negligence, the liability of the Minerva Bio- labs GmbH under these Conditions (whether by reason of breach of contract, tort, delict or otherwise) shall be limited to the price paid by the Customer for the relevant products. In no event shall the Minerva Biolabs GmbH be liable for any indirect damages including but not limited to, damages for loss of business or revenue, loss of profits or loss of goodwill or other damages consequential upon the same regardless of whether or not the Minerva Biolabs GmbH has been infor- med of the possibility of such damages or is negligent. The Minerva Biolabs’ liability for selling and delivering the products is as expressly stated and limited by these Conditions. All other warranties, rights, obligations, representations, undertakings liabilities, terms and or conditions (whether they are express or implied, or arise in contract, tort delict or otherwise, irrespective of the negligence of the Minerva Biolabs GmbH) in connection with the products and all such warranties, rights, obligations, representations, liabilities, terms or conditions are hereby expressly excluded.

Quality Control The Minerva Biolabs GmbH will endeavour to comply with all applicable regulations and other legal requirements concerning sale and delivery of the products.

Termination The Company may defer or suspend the performance of the contract and or treat these Conditions as determined if the customer: breaches any of these Conditions; undergoes insolvency proceedings of any nature or enters into any arrangement with its creditors. Termination for whatever reason shall not affect the rights and remedies accrued by the parties as at the date of such termination or any rights or obligations which due to the nature thereof are intended to survive termination.

Miscellaneous If the Minerva Biolabs GmbH is delayed or prevented from delivering the products due to circumstances beyond its control, the Minerva Biolabs GmbH may cancel or suspend the contract without any liabil- ity (subject to providing the customer with the appropriate refund in the event that such delay or pre- vention is not due to an act or omission of the customer). These Conditions shall be governed by and construed in accordance with German Law. The customer hereby submits itself to the non-exclusive jurisdiction of the German Courts.

90 91 Cell Culture PCR Cycler Food & Water Nucleic Acid DNA Standards & Contract Control Validation Assays Extraction Cleaning Products Manufacturing

Index 1 Color Compensation 37 G Mycoplasma Elimination 20 10CFU Standards 18, 19, 76 Color Compensation Kit 37 Gel electrophoresis 13, 14, 15, 25, 35 Mycoplasma fermentans 19, 73, 75, 77 Conditions 89 Genomic DNA Extracts 72, 73 Mycoplasma gallisepticum 19, 73, 75, 77 A Contamination 3, 10, 13, 16, 22, 23, 24, 26, Geobacillus stearothermophilus 73 Mycoplasma genitalium 73 Acinetobacter bamanii 73 27, 29, 30, 41, 42, 48, 49, 51, 52, 53, 54, 56, Goat 54, 56 Mycoplasma hominis 73 Acholeplasma laidlawii 10, 19, 73, 75, 77 57, 58, 60, 61, 78, 79, 80, 81, 82 GU:CFU Ratio 18, 76 Mycoplasma hyorhinis 11, 73, 75, 77 Aeromonas hydrophila 73 Contaminated Food 49 Mycoplasma-Off™ 26, 28, 29 Advance 12, 14, 35, 54, 59 Contract manufacturing 3, 84 H Mycoplasma orale 19, 73, 75, 77 AFNOR 42, 44 Culture Method 11, 18, 76 Halal 54, 57 Mycoplasma penetrans 73 Antibiotics 10, 20, 24, 26, 27 Cycler Check 35, 36 Horse 54, 56 Mycoplasma pneumoniae 19, 73, 75, 77 AquaScreen® 40, 41 Cycler Validation 32 Mycoplasma salivarium 73 AquaScreen® Escherichia coli 46 I Mycoplasma Set 18, 19, 76, 77 AquaScreen® FastExtract 42 D Incubators 26, 28, 30, 78, 82 Mycoplasma species 13, 16, 18, 76, AquaScreen® Legionella pneumophila 44 Decontamination 26, 78, 79, 80, 81 ISO 13485 3, 34-36, 86 Mycoplasma synoviae 19 AquaScreen® Legionella species 43 Disinfection 3, 26, 28, 29, 30, 87, 82 ISO 9001 3 Mynox® 20, 21, 22, 88 AquaScreen® Pseudomonas 45 DNA 3, 10-19, 24, 25, 31, 40 -61 Mynox® Gold 21, 23 AquaScreen® Escherichia coli DNA Extraction 16, 17, 18, 40, 41, 42, 50-61, K Aspergillus fumigatus 73 65, 76 Klebsiella pneumoniae 73 N ATMPs 11, 16, 17 Donkey 54, 56, 57 Klebsiella pneumoniae, ESBL+ 73 Neisseria meningitidis 73

B E L O Bacteria Detection 24 Elimination 3, 20, 22, 23 Lab Clean 81 Onar® Bacteria 24, 25 Bacillus cereus 73 Endpoint PCR 13, 14, 15, 25 Lactobacillus acidophilus 73 OneStep 12, 15, 35, 58, 60 Bacillus thueringiensis 73 Enterobacter aerogenes 73 Legionella 40, 41, 42, 43, 44, 73, 75 Bacillus subtilis 24, 73 Enterococcus casseliflavus 73 Legionella dumofii 73 P Bacterial Contamination 24, 48 Enterobacter cloacae 73 Legionella jordanis 73 Payment 89 Beef 54, 56 Enterococcus durans 73 Legionella pneumophila 40, 43, 44, 73, 75 PCR Calibration 74 Blood 66 Enterococcus faecalis 73 Legionella pneumophila subsp. fraseri 73 PCR Clean 79, 80 Bordetella parapertussis 73 Enterococcus faecium 73 Legionella pneumophila subsp. pascullei 73 PCR Cycler Check 34,35 Bordetella pertussis 73, 75 Enterococcus hirse 73 Licenses 88 PCR Cycler qualification 3 Burkholderia capacia73 Escherichia coli 24, 26, 28, 40, 46, 51, 52, 53, LightCycler 88 PCR Quantification 43-46, 74 73, 75 Listeria monocytogenes 51-53 PCR Quantification Standard 43-46, 74 C Escherichia coli 0157:H7 73 Listeria spp. 51-53 Pharma 12 Camel 54, 56 European Pharmacopoeia 11, 16, 18 ,76 Plasmid 34, 79 Campylobacter jejuni 73 ExtractNow™ 50-69 M Polymerases 5 Campylobacter spp. 51, 52, 53 ExtractNow™ Food Control 48-53 MB Taq DNA Polymerase 13, 31 Pork 54, 56, 57 Candida albicans 26, 28, 29, 73 ExtractNow™ Meat ID 54-57 Meat 3, 54-61 Prevention 10, 24, 26, 41, 48, 49, 55, 90 Candida glabrata 73 ExtractNow™ Vegan 58-61 Meat ID™ Halal 54, 57 Prime 24 Candida guiliermondii 73 Extraction 12, 16-18, 40, 42, 51-61, 64-69, Meat ID™ Screen 54, 56 Proteinase K 17, 65, 66, 69 Candida haemulonii 73 72, 74, 76 Meat identification 3 Proteus mirabilis 26, 28, 29, 73, Candida tropicalis 73 Mera Scientific 3 Proteus vulgaris 73 Cancelation 89 F Methicilin-resistant Staphylococcus aureus Pseudomonas aeruginosa 26, 28, 29, 40, 45, Cell Culture Contamination 27 FastExtract 41, 42, 44, 46 (MRSA) 73 73, 75 Chicken 54, 56 Fish 54, 56 Micrococcus luteus 73 Citrobacter freundii 73 Fluoribacter bozemanae 73 Minerva Analytix 3, 87 Q Citrobacter koseri 73 Foodborne Pathogens 48, 51, 52 Morganella morganii 73 qPCR 12, 16, 36, 37, 40, 41, 43, 44, 45, 46, Cleaner 81 Food Chain Production 48 Mycoplasma 10, 11, 12, 13, 16, 17, 18, 19, 48, 49, 51, 54, 56-58, 60, 61, 74, 81, 86-88 Clostridium perfringens 73 Food Control™ 48-53 20, 21, 22, 23, 26, 27, 28, 29, 73, 75 qPCR Cycler Check 36 Clostridium acetobutylicum 73 Food Safety 54 Mycoplasma arginini 19, 73, 75, 77 Quality Management System 3, 34 Clostridium perfringens 51, 52, 53, 73 Food 3, 48-61 Mycoplasma arthritidis 73 Quantification 16, 18, 43-46 Colony Forming Units 18, 76 Mycoplasma Detection 12, 18, 22, 23, 27, 76 Quantification Standards 16, 74

92 93 R Venor®GeM Advance 14 Real-time qPCR 36, 37 Venor®GeM Classic 13 Removal 3, 27, 28, 69, 79, 80 Venor®GeM OneStep 15 Removal of DNA 79, 80 Venor®GeM Sample Preparation Kit 17 RNA 3, 24, 74, 79, 80, 82 Verification 34 Virus 10, 12, 21, 22, 23, 24, 25, 26, 28, 29, 69 S Virus DNA 69 Salmonella enterica 51-53, 73 Salmonella spp. 51-53 W Sensitivity 11, 13, 16, 18, 31, 37, 40, 74, 77 Water 15, 16, 25, 26, 30, 38, 40, 41, 42 , 43, Sensitivity Standards 13, 16, 18, 76 44, 45, 46, 50, 51, 52, 56, 57, 58, 59, 78, 82 Serratia marcescens 73 Water pathogen 40 Service 3, 34, 86, 87, 88 WaterShield 30, 82 Sheep 54, 56 Wipes 29, 78, 80 Shiga Toxin 1 51-53 Shiga Toxin 2 51-53 Y Shigella flexneri 73 Yersinia enterocolitica 51-53, 73 Shigella sonnei 73 Yersinia pseudotuberculosis 73 Shigella spp. 51-53 Standards 70, 72, 74, 76 Z Staphylococcus aureus 26, 28, 29, 73 Zebra 54, 56 Staphylococcus epidermidis 73 ZellShield 27 Staphylococcus hominis 73 Staphylococcus haemolyticus 73 Streptococcus bovis 73 Streptococcus dysgalactiae 73 Streptococcus mutans 73 Streptococcus sanguinis 73 Staphylococcus saprophyticus 73 Stenotrophomonas maltophilia 73 Specifity Standards 72, 73 Spiroplasma citri 19, 73, 75, 77 Supernatants 17, 69

T Taq DNA Polymerase 31 Temperature control 34 Terms 89 Trademarks 88 Turkey 54, 56

U Ureaplasma urealyticum 73

V Vegan 3, 54, 55, 58-61, 88 Vegan Control™ Advance 58, 61 Vegan Control™ OneStep 58, 60 Validation 3, 11, 13, 16, 18, 25, 32, 76 Venor®GeM 12, 13, 14, 15, 16, 17, 26, 27

94 95 In Qualification We Trust! Cycler Check™

Beef or no Beef? That’s the question! Meat ID™

Surface Disinfection Mycoplasma Off™

The Excellent Way to Isolate Nucleic Acid ExtractNow™

Still using Pen/Strep? It’s time to change! ZellShield®

Highly Effective and Easy Decontamination PCR Clean™

Minerva Biolabs GmbH For ordering: Koepenicker Str. 325 Internet: shop.minerva-biolabs.com 12555 Berlin / Germany E-mail: [email protected] Tel. +49 (0)30 2000437-0 Fax: +49 (0) 30 2000437-9 [email protected] Do not hesitate to contact us: Mo - Fr 8.00 - 16.30 www.minerva-biolabs.com [email protected]