Biomaterials: Design, Manufacturing Services and Products

Living Immunoassay Excellence Biokit is a privately owned biotechnological company that is part of Werfen. It was founded in 1973 and is aimed at the research, development, manufacture and worldwide distribution of clinical diagnostic reagents and systems.

Our knowledge and experience mainly involve in vitro diagnostic markers, based on antigen- antibody reactions, in the fields of infectious diseases and serum proteins, among others.

Biokit’s mission is to become the partner of choice as a centre of excellence for immunoassay by providing innovative OEM solutions (products & services) to major IVD players.

Innovation Quality Commitment

Biokit ranks among the top centres of Biokit is commited with the quality in all Customers and patients benefit from the excellence for immunoassay development the activities, offering maximum quality efficiency of a team of more than 270 highly and manufacturing in the industry. standards in all the products and services. qualified and specialised professionals, Our focus on technological advances ensures who apply their enthusiasm, energy and that our portfolio continuously improves The Quality Assurance Department at Biokit dedication on a daily basis in order to and evolves. Biokit’s innovative nature is is responsible for the Overall Quality of provide hospitals, blood banks and IVD strengthened through close relationships the Company. All processes are subject to OEM partners with high quality systems with the most prestigious universities and strict controls, from the conception of and and reagents. biotechnology research centres around the research into a new product, up to its final world in order to offer the best quality and manufacturing and marketing. state-of-the-art products. Compliance with various international As experts in Infectious Disease Serology, we standards is verified at all times. offer a wide range of products implementing a variety of technologies, most notably, The quality systems of Biokit, S.A. have been chemiluminescence. registered by UL to the ISO 13485:2003 Standard (certificate number A12230).

2 Biomaterials Catalogue Biomaterials: Design and Large Production Capacity

Biokit offers its expertise in design and manufacturing biomaterials for large IVD manufacturers with proven results in diagnostic kits. More than 80 companies in the IVD industry rely on biomaterials and specialized OEM Products and Services from Biokit.

Abbreviations

A280 Absorbance at 280 nm HIV Human Immunodeficiency Virus Ab Antibody HPLC High-performance liquid chromatography ADV Adeno virus IBES Improved Baculovirus Expression System Ag Antigen IVD In Vitro Diagnostics CLIA Chemiluminescence mAb Monoclonal Antibody CMV Citomegalovirus Mfg PT Manufacturing Prototype lots CPE Citopatic effect Manufacturing Verification Mfg V&V and Validation Lots DGU Density Gradient Ultracentrifugation Native ELISA Enzyme-Linked ImmunoSorbent Assay Nat NaCl-Tris-EDTA buffer FDA Food and Drug Administration NTE Polyclonal Antibody GF Gel filtration pAb Recombinant HBV B Virus Rec HCV Virus Sodium Dodecys Sulfate - SDS-PAGE Polyacrylamide gel electrophoresis N-2-hydroxyethylpiperazine-N-2-ethane HEPES sulfonic acid TFF Tangential flow filtration Biomaterials Catalogue 3 Biomaterials Manufacturing Capabilities & Services

Expression systems

Growth Method Equipment Capacity Human & monkey cells Roller Bottles 90 – 1000 bottles* Spinner Flasks 1 Liter Hollow Fiber 2.1 m2 Insect & CHO cells Shaker Incubators 1 – 5 Liter Hybridomas Stirrer Tank Bioreactor 2 – 50 Liter Analytical characterization Wave 25 – 100 Liter Methodology Description Shaker Incubators 1 – > 10 Liter Bacteria & Yeast Spectrophotometry Protein Measurement Bioreactors 5 – 50 Liter PAGE (reducing, IBES technology** Insect rearing 0,5 mg/larva or pupa Electrophoresis Profile non-reducing conditions) 2 2 HPLC AKTA or Waters Systems * Bottles of 810 cm or 1.700 cm capacity ** IBES (Improved Baculovirus Expression System) Dot Blot Western Blot Functional Immuno test Performance (ELISA, Latex or CLIA technology) Biacore * Octet * Purification * only during feasibility stage Biomaterials Technologies Capacity

Salt Precipitation n/a

Human Plasmatic Density Gradient n/a Proteins Ultracentrifugation (DGU) Recombinant Tangential Flow Filtration (TFF) n/a Antigens Native Antigens Preparative Chromatography: Monoclonal Gel Filtration (GF) 10 mL - > 20 Liter Antibodies • Polyclonal • Ion Exchange (anionic, cationic) 10 mL - > 2 Liter Antibodies • Affinity: metal-, tagged-, 10 mL - > 2 Liter immuno-binding

Biokit is dedicated to obtaining highly purified Biokit offers its expertise in biomaterials manufacturing for large antigens and antibodies • Viral, bacterial and parasitological cultures IVD manufacturers. If you need to outsource your in-house • Synthetic peptides and recombinant proteins manufactured biomaterials, we can offer a high professional and • Monoclonal antibodies from hybridoma cell cultures dedicated solution. • Polyclonal antibodies from rabbit, goat and guinea pig We can implement your manufacturing procedures (expression, purification and characterization in our facilities to supply you with the high quality biomaterials you need in a timely and costly-efficient manner.

4 Biomaterials Catalogue Large-Scale Baculovirus Expression System Service

Biomaterials Development & Manufacturing Services

FEASIBILITY DEVELOPMENT

Concept Phase Process Phase Development

Protein Design Process Optimization Mfg V&V Batches Expression System Protein Characterization Functional Evaluation Protein Analysis Mfg PT Batches

Biokit has implemented innovative technology Biokit offers its expertise in Large-Scale Baculovirus Expression for the large-scale production of recombinant proteins obtained in Baculovirus systems. development and manufacturing for large IVD manufacturers. This methodology uses an “In Vivo” expression If you are experiencing challenges in the scalability of recombinant system in which insect larvae are used as living bioreactors (IBES®*). proteins using the Baculovirus system, we can help you through our innovative IBES® technology. This process enables: • High batch-to-batch reproducibility • Rapid and linear scale up production process Using this technology, we can scale up your manufacturing • Optimal recombinant protein conformation expression procedure as well as implement your purification and

* IBES® is a technology licensed by ALGENEX S.L. characterisation processes in our facilities. In this way, we will be able to supply you with the amount of recombinant protein you require with no changes in the biomaterial functionality of your assay.

Biomaterials Catalogue 5 Biomaterials Products

Index

Biomaterials: Technologies and applications p. 7

Native antigens p. 8

Recombinant antigens p. 12

Polyclonal antibodies p. 19

Monoclonal antibodies p. 23

Sera p. 25

6 Biomaterials Catalogue Biomaterials: IVD technologies Processes *Technologies/Applications

Product Description Page Turbidimetry ELISA Chemiluminescence Rapid Test Purification Immunization Virus Native antigens Hepatitis B Surface6 (ad Subtype) 9 Hepatitis B Surface Antigen (ay Subtype) 9 Recombinant antigens Recombinant HBs Antigen (ad Subtype) 13 Recombinant HBs Antigen (ay Subtype) 13 Recombinant HBc Antigen 14 Polyclonal antibodies Anti-HBs Rabbit IgG pAb 20 Anti-HBs Goat IgG pAb 20 Anti-HBs Guinea Pig IgG pAb 20 Anti-rHBc Rabbit IgG pAb 21 Monoclonal antibodies Anti-HBs mAb (1DE2) 24 Sera Anti-HBs Goat Serum 26 Anti-HBs Rabbit Serum 26 Hepatitis C Virus Recombinant antigens Recombinant HCV Polypeptide 14 Recombinant HCV NS3 Polypeptide 15 Treponema pallidum Recombinant antigens Recombinant p15 Treponema pallidum Ag 15 Recombinant p15 (II) Treponema pallidum Ag 15 Recombinant p17 Treponema pallidum Ag 15 Recombinant p47 Treponema pallidum Ag 16 Recombinant H-p17 Treponema pallidum Ag 16 Recombinant H-p47 Treponema pallidum Ag 16 Polyclonal antibodies Anti-Treponema pallidum Rabbit IgG pAb 21 Sera Anti-Treponema pallidum Rabbit Serum 26 Toxoplasma gondii Native antigens Toxoplasma Gondii Soluble Ag 11 Rubella Virus Native antigens Rubella Antigen Grade A 10 Rubella Antigen Grade B 10 Recombinant antigens Recombinant Rubella E1 Antigen 17 Recombinant Rubella E2 Antigen 17 Virus Recombinant antigens Recombinant gG1 Protein HSV-1 17 Recombinant gG2 Protein HSV-2 18 Cytomegalovirus Native antigens Cytomegalovirus Antigen 11 Adenovirus Monoclonal antibodies Anti-Adenovirus mAb (2/6) 24 Anti-Adenovirus mAb (20/11) 24 Sera Anti-Rotavirus Rabbit Serum 26 Polyclonal antibodies Anti-Rotavirus Rabbit IgG pAb 22 Epstein-Barr Virus Native antigens Paul-Bunnell Antigen 11 Trypanosoma cruzy Recombinant antigens Recombinant TcF Chagas Ag 18 Rheuma Recombinant antigens Recombinant Streptolysin-O 18 Recombinant Streptolysin-O Stabilized 18 Polyclonal antibodies Anti-Streptolysin O Rabbit IgG pAb 21 Anti-C Reactive Protein Rabbit IgG pAb 22

* Please note this table is merely indicative. For further technical information please contact [email protected] Biomaterials Catalogue 7 Native antigens

Product Description Presentation Reference Storage Page

Hepatitis B Surface Antigen (ad Subtype) 1 mg/vial 3000-5201 - 20 ºC 9

Hepatitis B Surface Antigen (ad Subtype) mg/custom size 3000-5200 - 20 ºC 9

Hepatitis B Surface Antigen (ay Subtype) 1 mg/vial 3000-5199 - 20 ºC 9

Hepatitis B Surface Antigen (ay Subtype) mg/custom size 3000-5198 - 20 ºC 9

Rubella Antigen Grade A 1 mg/vial 3000-5202 - 70 ºC 10

Rubella Antigen Grade A mg/custom size 3000-5204 - 70 ºC 10

Rubella Antigen Grade B 1 mg/vial 3000-5203 - 70 ºC 10

Rubella Antigen Grade B mg/custom size 3000-5205 - 70 ºC 10

Toxoplasma Gondii Soluble Ag 1 mL/vial 3000-5256 - 20 ºC 11

Toxoplasma Gondii Soluble Ag mL/custom size 3000-5252 - 20 ºC 11

Cytomegalovirus Antigen mg/custom size 3000-5260 - 70 ºC 11

Paul-Bunnell Antigen 1 mg/vial 3000-5286 - 70 ºC 11

Paul-Bunnell Antigen mg/custom size 3000-5287 - 70 ºC 11

8 Biomaterials Catalogue Product Description Presentation Reference Storage

Hepatitis B Virus

Hepatitis B Surface Antigen (ad Subtype) 1 mg/vial 3000-5201 - 20 ºC**

Hepatitis B Surface Antigen (ad Subtype) mg/custom size* 3000-5200 - 20 ºC**

* For large quantities, packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Human plasma. Subtype ad. Form HBsAg in phosphate buffered saline pH 7.4. Purification Three ultracentrifugation steps. Purity 1. Silver stained SDS-PAGE under reducing conditions reveals two major bands correspoding to p24 and gp27. Bands corresponding to pre-S proteins, dimers, and 69 kDa protein are also detected. 2. 20 nm spherical particles were detected by electron microscopy, as well as rod particles in some lots. Complete virions (Dane particles, 42 nm) were not observed (done initially when the protocol was established). Protein concentration 2-3 mg/ml (A280/3.726). Preservative No preservative added. Inactivation Heat inactivated after purification (10 hours at 60 ºC). Although inactivated handle with appropriate precautions. HIV 1/2-Ab and HCV-Ab tests The human plasma units used as starting material have been found non-reactive for HIV 1/2 and HCV antibodies using a FDA approved assay.

Hepatitis B Surface Antigen (ay Subtype) 1 mg/vial 3000-5199 - 20 ºC**

Hepatitis B Surface Antigen (ay Subtype) mg/custom size* 3000-5198 - 20 ºC**

* For large quantities, packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Human plasma. Subtype ay. Form HBsAg in phosphate buffered saline pH 7.4. Purification Three ultracentrifugation steps. Purity 1. Silver stained SDS-PAGE under reducing conditions reveals two major bands correspoding to p24 and gp27. Bands corresponding to pre-S proteins, dimers, and 69 kDa protein are also detected. 2. 20 nm spherical particles were detected by electron microscopy, as well as rod particles in some lots. Complete virions (Dane particles, 42 nm) were not observed (done initially when the protocol was established). Protein concentration 2-3 mg/ml (A280/3.726). Preservative No preservative added. Inactivation Heat inactivated after purification (10 hours at 60 ºC). Although inactivated handle with appropriate precautions. HIV 1/2-Ab and HCV-Ab tests The human plasma units used as starting material have been found non-reactive for HIV 1/2 and HCV antibodies using a FDA approved assay.

Biomaterials Catalogue 9 Native antigens

Product Description Presentation Reference Storage

Rubella Virus

Rubella Antigen Grade A 1 mg/vial 3000-5202 - 70 ºC**

Rubella Antigen Grade A mg/custom size* 3000-5204 - 70 ºC**

* For large quantities, packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Tissue culture. Virus Strain: HPV-77. Host: Vero cells (african green monkey kidney). Buffer used Rubella antigen in approx. 20% sucrose / 0.02% SDS / NTE buffer. Purification Purified by ultracentrifugation. Purity > 90%. The three major bands standard for Rubella antigen are detected by SDS-PAGE. Protein concentration 0.5-1.5 mg/ml (modified Warburg-Christian method). Specific antigenic activity > 1000 EU/mg (measured by an “in house” capture ELISA). Preservative No preservative added. Inactivation Inactivated by detergent treatment (0.02% SDS). Although inactivated handle with appropiate precautions.

Rubella Antigen Grade B 1 mg/vial 3000-5203 - 70 ºC**

Rubella Antigen Grade B mg/custom size* 3000-5205 - 70 ºC**

* For large quantities, packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Tissue culture. Virus Strain: HPV-77. Host: Vero cells (african green monkey kidney). Buffer used Rubella antigen in approx. 40% sucrose / 0.02% SDS / NTE buffer. Purification Purified by ultracentrifugation. Purity > 90%. The three major bands standard for Rubella antigen are detected by SDS-PAGE. Protein concentration 0.1-0.5 mg/ml (modified Warburg-Christian method). Specific antigenic activity > 600 EU/mg (measured by an “in house” capture ELISA). Preservative No preservative added. Inactivation Inactivated by detergent treatment (0.02% SDS). Although inactivated handle with appropiate precautions.

10 Biomaterials Catalogue Product Description Presentation Reference Storage

Toxoplasma gondii

Toxoplasma gondii Soluble Ag Treated 1 mL/vial 3000-5256 - 20 ºC**

Toxoplasma gondii Soluble Ag Treated mL/custom size* 3000-5252 - 20 ºC**

* For large quantities, packaging available upon request - minimum size 5 ml/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mL. Source Intraperitoneal exudates from infected mice / Strain: RH. Form Detergent treated Toxoplasma gondii suspension in glycine buffered saline pH 9.0. The purity of the original material is higher than 100 toxoplasmas per cell. Protein concentration 2-8 mg/ml (Biuret method). Preservative < 0.1% sodium azide.

Cytomegalovirus

Cytomegalovirus Antigen mg/custom size* 3000-5260 - 70 ºC**

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Tissue culture / Virus Strain: AD-169 / Host: Human foreskin cells. Form CMV antigens from all virus cycle replication in NTE buffer pH 8.0. Contains residual host cellular material. Protein concentration 0.4-0.7 mg/ml (modified Warburg-Christian method). Preservative No preservative added. Inactivation Detergent inactivated (0.015% SDS). Although inactivated handle with appropiate precautions. Infectivity assay After 15 days of incubation on a monolayer of Human foreskin cells, no cytopathic effect (CPE) must be observed. Handling Sonication is recommended prior to use.

Epstein-Barr Virus

Paul-Bunnell Antigen 1 mg/vial 3000-5286 - 70 ºC**

Paul-Bunnell Antigen mg/custom size* 3000-5287 - 70 ºC**

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Bovine red blood cells Buffer used None Purification Organic solvents extraction followed by ion Exchange chromatography. Protein concentration 0.5-2.5 mg/ml (Abs 280nm). Preservative 0.5 g/l sodium azide.

Biomaterials Catalogue 11 Recombinant Antigens

Product Description Presentation Reference Storage Page

Recombinant HBs Antigen (ad Subtype) 50 mg/custom size 3000-5269 2-8 ºC 13

Recombinant HBs Antigen (ay Subtype) 50 mg/custom size 3000-5270 2-8 ºC 13

Recombinant HBc Antigen 1 mg/vial 3000-5100 -20 ºC 14

Recombinant HBc Antigen mg/custom size 3000-5102 -20 ºC 14

Recombinant HCV Capsid Polypeptide mg/custom size 3000-5103 -70 ºC 14

Recombinant HCV NS3 Polypeptide mg/custom size 3000-5104 -70 ºC 15

Recombinant p15 Treponema pallidum Ag mg/custom size 3000-5245 -70 ºC 15

NEW Recombinant p15 (II) Treponema pallidum Ag mg/custom size 3000-5289 -70 ºC 15

Recombinant p17 Treponema pallidum Ag mg/custom size 3000-5280 -70 ºC 15

Recombinant p47 Treponema pallidum Ag mg/custom size 3000-5284 -70 ºC 16

Recombinant H-p17 Treponema pallidum Ag mg/custom size 3000-5254 -70 ºC 16

Recombinant H-p47 Treponema pallidum Ag mg/custom size 3000-5263 -70 ºC 16

Recombinant Rubella E1 Antigen 50 mg/custom size 3000-5261 -70 ºC 17

Recombinant Rubella E2 Antigen 50 mg/custom size 3000-5262 -70 ºC 17

Recombinant gG1 Protein HSV-1 0.5 mg/vial 3000-5288 -70 ºC 17

Recombinant gG1 Protein HSV-1 mg/custom size 3000-5279 -70 ºC 17

Recombinant gG2 Protein HSV-2 0.5 mg/vial 3000-5282 -70 ºC 18

Recombinant gG2 protein HSV-2 mg/custom size 3000-5283 -70 ºC 18

NEW Recombinant TcF Chagas Ag 1 mg/vial 3000-5290 -70 ºC 18

NEW Recombinant TcF Chagas Ag mg/custome size 3000-5291 -70 ºC 18

Recombinant Streptolysin-O 5 mg/vial 3000-5258 -70 ºC 18

Recombinant Streptolysin-O Stabilized 5 mg/vial 3000-5259 -70 ºC 18

12 Biomaterials Catalogue Product Description Presentation Reference Storage

Hepatitis B Virus

Recombinant HBs Antigen (ad Subtype) 50 mg/custom size* 3000-5269 2-8 ºC

* Packaging available upon request - minimum order 50 mg and minimum size 5mg/vial.

Specifications Selling unit mg. Source Transformed Pichia pastoris. Subtype ad. Form rHBsAg in Tris-HCl buffer pH 8.0. Purification Immunoaffinity chromatography. Purity 1. SDS-PAGE under reducing conditions reveals one major band at 24 kDa which corresponds to the monomer. Bands at 44 and 64 kDa are also detected and correspond to monomer multimerization. 2. 20 nm spherical particles were detected by electron microscopy (done initially when the protocol was established). Protein concentration 0.8-1.5 mg/ml. Preservative No preservative added.

Recombinant HBs Antigen (ay Subtype) 50 mg/custom size* 3000-5270 2-8 ºC

* Packaging available upon request - minimum order 50 mg and minimum size 5mg/vial.

Specifications Selling unit mg. Source Transformed Pichia pastoris. Subtype ay. Form rHBsAg in Tris-HCl buffer pH 8.0. Purification Immunoaffinity chromatography. Purity 1. SDS-PAGE under reducing conditions reveals one major band at 24 kDa which corresponds to the monomer. Bands at 44 and 64 kDa are also detected and correspond to monomer multimerization. 2. 20 nm spherical particles were detected by electron microscopy (done initially when the protocol was established). Protein concentration 0.8-1.5 mg/ml. Preservative No preservative added.

Biomaterials Catalogue 13 Recombinant Antigens

Product Description Presentation Reference Storage

Hepatitis B Virus

Recombinant HBc Antigen 1 mg/vial 3000-5100 -20 ºC**

Recombinant HBc Antigen mg/custom size* 3000-5102 -20 ºC**

* For large quantities, packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications

Selling unit mg. Source Transformed Escherichia coli. Form rHBcAg in 9.6 mM phosphate buffered saline, 142 mM NaCl, pH 7.4 Purification Purified by ultracentrifugation. Purity 1. A major high molecular weight peak is obtained by gel filtration through Superose 6. Some minor peaks of low molecular weight can be observed. 2. SDS-PAGE under reducing conditions reveals a main 23 kDa band and several other bands. 3. A major band at about 23 kDa and a minor band at 40 kDa were detected by Western blot using IgG from rabbit immunized with HBcAg from liver of HBV infected chimpanzee (done initially when the protocol was established). 4. Round particles of about 30 nm in diameter were detected using immunoelectron microscopy with human anti-HBc (done initially when the protocol was established). Protein concentration 0.2-1.0 mg/ml (Lowry method). Preservative No preservative added.

Hepatitis C Virus

Recombinant HCV Capsid Polypeptide mg/custom size* 3000-5103 -70 ºC**

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications

Selling unit mg. Source Transformed Escherichia coli. Buffer used Acetate buffered 0.4 M NaCl, pH 5.5. Purification Ion exchange chromatography. Protein concentration 0.5-2.0 mg/ml (A280). Preservative No preservative added.

14 Biomaterials Catalogue Product Description Presentation Reference Storage

Hepatitis C Virus

Recombinant HCV NS3 Polypeptide mg/custom size* 3000-5104 -70 ºC** * Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used Tris-HCl buffered saline pH 8.6. Purification Affinity chromatography. Protein concentration 0.5-2.0 mg/ml (A280). Preservative No preservative added.

Treponema pallidum

Recombinant p15 Treponema pallidum Ag mg/custom size* 3000-5245 -70 ºC**

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used 40 mM Tris-HCl, 200 mM NaCl, pH 8.0. Purification Affinity chromatography. Protein contentration 2-5 mg/ml (Bradford method) Preservative No preservative added.

Recombinant p15 (II) Treponema pallidum Ag mg/custom size* 3000-5289 -70 ºC**

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications NEW Selling unit mg. Source Transformed Escherichia coli. Buffer used 50 mM Tris-HCl, 300 mM NaCl, pH 8.0. Purification Affinity chromatography.

Protein contentration 3 - 7 mg/ml (A280 x 0.74). Preservative No preservative added.

Recombinant p17 Treponema pallidum Ag mg/custom size* 3000-5280 -70 ºC**

* Packaging available upon request - minimum size 2 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used 50 mM Tris-HCl, 300 mM NaCl, PH 8.0. Purification Ion exchange and affinity chromatography. Protein contentration 8-12 mg/ml (A280 x 0.78). Preservative No preservative added.

Biomaterials Catalogue 15 Recombinant Antigens

Product Description Presentation Reference Storage

Treponema pallidum

Recombinant p47 Treponema pallidum Ag mg/custom size* 3000-5284 -70 ºC** * Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used 50 mM Tris-HCl, 300 mM NaCl, pH 8.0. Purification Affinity chromatography. Protein contentration 4-6 mg/ml (A280 x 0.8). Preservative No preservative added.

Recombinant H-p17 Treponema pallidum Ag mg/custom size* 3000-5254 -70 ºC**

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used 10 mM Tris-HCl, 300 mM NaCl, pH 8.0. Purification Metal affinity chromatography. Protein contentration 2-5 mg/ml (A280 x 1.38). Preservative No preservative added.

Recombinant H-p47 Treponema pallidum Ag mg/custom size* 3000-5263 -70 ºC**

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used 50 mM Tris-HCl, 300 mM NaCl, pH 8.0. Purification Metal affinity chromatography. Protein contentration 2-5 mg/ml (A280 x 0.91). Preservative No preservative added.

16 Biomaterials Catalogue Product Description Presentation Reference Storage

Rubella Virus

Recombinant Rubella E1 Antigen 50 mg/custom size* 3000-5261 -70 ºC**

* Packaging available upon request - minimum order 50 mg and minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used Tris buffered saline pH 8.5. Purification Affinity chromatography. Protein concentration 1-3 mg/ml (A280 x 0.57). Preservative No preservative added.

Recombinant Rubella E2 Antigen 50 mg/custom size* 3000-5262 -70 ºC**

* Packaging available upon request - minimum order 50 mg and minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Transformed Escherichia coli. Buffer used Tris buffered saline pH 8.5. Purification Affinity chromatography. Protein concentration 1-3 mg/ml (A280 x 0.71). Preservative No preservative added.

Herpes Simplex-1 Virus

Recombinant gG1 Protein HSV-1# 0.5 mg/vial 3000-5288 -70 ºC**

Recombinant gG1 Protein HSV-1# mg/custom size* 3000-5279 -70 ºC**

* Packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing. # This product is manufactured using IBES® technology licensed by ALGENEX S.L.

Specifications Selling unit mg. Source Baculovirus infected Trichoplusia ni. Buffer used 10 mM HEPES, 50 mM NaCl, pH 7.5. Purification Ion exchange and affinity chromatography. Protein concentration 0.5-2 mg/ml (subindex x 6.95). Preservative No preservative added.

Biomaterials Catalogue 17 Recombinant Antigens

Product Description Presentation Reference Storage

Herpes Simplex-2 Virus Recombinant gG2 Protein HSV-2# 0.5 mg/vial 3000-5282 -70 ºC** Recombinant gG2 Protein HSV-2# mg/custom size* 3000-5283 -70 ºC**

* Packaging available upon request - minimum size 5 mg/vial. Specifications ** Avoid repeated freezing and thawing. Selling unit mg. # This product is manufactured using IBES® technology licensed by ALGENEX S.L. Source Baculovirus infected Trichoplusia ni. Buffer used 50 mM HEPES, 500 mM NaCl, pH 8.2. Purification Ion exchange and affinity chromatography. Protein contentration 0.8-1.5 mg/ml (A280 x 5.45). Preservative No preservative added.

Trypanosoma cruzy Recombinant TcF Chagas Ag 1 mg/vial 3000-5290 -70 ºC** Recombinant TcF Chagas Ag mg/custom size* 3000-5291 -70 ºC**

* Packaging available upon request - Specifications minimum size 1 mg/vial. NEW ** Avoid repeated freezing and thawing. Selling unit mg. Source Transformed Escherichia coli. Buffer used 10 mM Tris-HCl, 300 mM NaCl, pH 8.0. Purification Metal affinity chromatography. Protein concentration 1 - 4 mg/ml (BCA method). Preservative No preservative added.

Streptolysin-O Recombinant Streptolysin-O mg/custom size* 3000-5258 -70 ºC**

* Packaging available upon request - minimum size 5 mg/vial. Specifications ** Avoid repeated freezing and thawing. Selling unit mg. Source Transformed Escherichia coli. Buffer used Tris-HCl buffered saline pH 8.5. Purification Metal affinity chromatography. Protein concentration 2-4 mg/ml (A280 x 0.79). Total antigenic activity (internal indirect method) > 4000 IU/ml. Specific antigenic activity > 1500 IU/mg of protein. Preservative No preservative added.

Recombinant Streptolysin-O stabilized mg/custom size* 3000-5259 -70 ºC**

* Packaging available upon request - minimum size 5 mg/vial. Specifications ** Avoid repeated freezing and thawing. Selling unit mg. Source Transformed Escherichia coli. Buffer used Tris-HCl buffered saline pH 8.2. Purification Metal affinity chromatography. Protein concentration 1-2 mg/ml (Lowry method). Total antigenic activity (internal indirect method) > 2500 IU/ml. Specific antigenic activity > 1250 IU/mg of protein. Preservative < 0.1% sodium azide.

18 Biomaterials Catalogue Polyclonal Antibodies

Product Description Presentation Reference Storage Page

Anti-HBs Rabbit IgG pAb 5 mg/vial 3000-5505 - 20 º C 20

Anti-HBs Rabbit IgG pAb mg/custom size 3000-5506 - 20 º C 20

Anti-HBs Goat IgG pAb 5 mg/vial 3000-5501 2 - 8 º C 20

Anti-HBs Goat IgG pAb mg/custom size 3000-5502 2 - 8 º C 20

Anti-HBs Guinea Pig IgG pAb 5 mg/vial 3000-5264 2 - 8 º C 20

Anti-HBs Guinea Pig IgG pAb mg/custom size 3000-5265 2 - 8 º C 20

Anti-rHBc Rabbit IgG pAb 5 mg/vial 3000-5527 - 20 º C 21

Anti-rHBc Rabbit IgG pAb mg/custom size 3000-5528 - 20 º C 21

Anti-Treponema pallidum Rabbit IgG pAb 5 mL/vial 3000-5529 - 20 º C 21

Anti-Streptolysin O Rabbit IgG pAb 5 mL/vial 3000-5000 - 20 º C 21

Anti-Rotavirus Rabbit IgG pAb 5 mg/vial 3000-5525 - 20 º C 22

Anti-Rotavirus Rabbit IgG pAb mg/custom size 3000-5526 - 20 º C 22

Anti-C Reactive Protein Rabbit IgG pAb 5 mg/vial 3000-5530 - 20 º C 22

Anti-C Reactive Protein Rabbit IgG pAb mg/custom size 3000-5531 - 20 º C 22

Biomaterials Catalogue 19 Polyclonal Antibodies

Product Description Presentation Reference Storage

Hepatitis B Virus

Anti-HBs Rabbit IgG pAb 5 mg/vial 3000-5505 -20 ºC** Anti-HBs Rabbit IgG pAb mg/custom size* 3000-5506 -20 ºC** * For large quantities, packaging available upon request - minimum size 10 mg/vial. ** Avoid repeated freezing and thawing.

Specifications

Selling unit mg. Source Serum of rabbits hyperimmunized with highly purified nHBsAg (ad + ay). Purification Immunoaffinity chromatography. Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa. Specificity Reacts with all “a” subtypes. Protein concentration 1-4 mg/ml (A280 x 0.71). Preservative < 0.1% sodium azide.

Anti-HBs Goat IgG pAb 5 mg/vial 3000-5501 2 - 8 º C Anti-HBs Goat IgG pAb mg/custom size* 3000-5502 2 - 8 º C

* For large quantities, packaging available upon request - minimum size 10 mg/vial.

Specifications Selling unit mg. Source Serum of goats hyperimmunized with highly purified nHBsAg (ad + ay). Purification Immunoaffinity chromatography. Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa. Specificity Reacts with all “a” subtypes. Protein concentration 1-3 mg/ml (A280 x 0.71). Preservative No preservative added.

Anti-HBs Guinea Pig IgG pAb 5 mg/vial 3000-5264 2 - 8 º C Anti-HBs Guinea Pig IgG pAb mg/custom size* 3000-5265 2 - 8 º C

* For large quantities, packaging available upon request - minimum size 10 mg/vial.

Specifications Selling unit mg. Source Serum of guinea pigs hyperimmunized with highly purified nHBsAg (ad + ay). Purification Immunoaffinity chromatography. Purity SDS-PAGE, under non-reducing conditions, shows one major band at approximately 150 kDa. Specificity Reacts with all “a” subtypes. Protein concentration 0.5-2.0 mg/ml (A280 x 0.78). Preservative < 0.1% sodium azide.

20 Biomaterials Catalogue Product Description Presentation Reference Storage

Hepatitis B Virus

Anti-rHBc Rabbit IgG pAb 5 mg/vial 3000-5527 -20 ºC** Anti-rHBc Rabbit IgG pAb mg/custom size* 3000-5528 -20 ºC** * For large quantities, packaging available upon request - minimum size 10 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Source Serum of rabbits hyperimmunized with rHBcAg. Purification Ammonium sulphate precipitation followed by ion exchange chromatography. Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa. Protein concentration 5-15 mg/ml (A280 x 0.71). Preservative 0.05% chloretone.

Treponema pallidum

Anti-Treponema pallidum Rabbit IgG pAb 5 mL/vial 3000-5529 -20 ºC* * Avoid repeated freezing and thawing.

Specifications Selling unit mL. Source Serum of rabbits hyperimmunized with Treponema pallidum. Purification Ammonium sulphate precipitation. Titer using RPR antigen ≥1:64 dilution. Preservative < 0.1% sodium azide.

Streptolysin-O

Anti-Streptolysin O Rabbit IgG pAb 5 mL/vial 3000-5000 -20 ºC* * Avoid repeated freezing and thawing.

Specifications

Selling unit mL. Source Serum of rabbits hyperimmunized with purified Streptolysin O. Purification Ammonium sulphate precipitation. Titer using a latex reagent of 200 IU/ml of anti-streptolysin O detection ≥1:16 dilution. Preservative < 0.1% sodium azide.

Biomaterials Catalogue 21 Polyclonal Antibodies

Product Description Presentation Reference Storage

Rotavirus

Anti-Rotavirus Rabbit IgG pAb 5 mg/vial 3000-5525 -20 ºC**

Anti-Rotavirus Rabbit IgG pAb mg/custom size* 3000-5526 -20 ºC**

* For large quantities, packaging available upon request - minimum size 10 mg/vial. ** Avoid repeated freezing and thawing.

Specifications

Selling unit mg. Source Serum of rabbits hyperimmunized with purified Rotavirus. Purification Ammonium sulphate precipitation followed by ion exchange chromatography. Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa. Protein concentration 5-15 mg/ml (A280 x 0.71). Preservative 0.05% chloretone.

C-Reactive Protein

Anti-C-Reactive Protein Rabbit IgG pAb 5 mg/vial 3000-5530 -20 ºC**

Anti-C-Reactive Protein Rabbit IgG pAb mg/custom size* 3000-5531 -20 ºC**

* For large quantities, packaging available upon request - minimum size 10 mg/vial. ** Avoid repeated freezing and thawing.

Specifications

Selling unit mg. Source Serum of rabbits hyperimmunized with purified human C-reactive protein. Purification Ammonium sulphate precipitation followed by ion exchange chromatography. Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa. Protein concentration 5-15 mg/ml (A280 x 0.71). Preservative 0.05% chloretone.

22 Biomaterials Catalogue Monoclonal Antibodies

Product Description Presentation Reference Storage Page

Anti-HBs mAb (1DE2) 50 mg/custom size 3000-5012 - 70 º C 24

Anti-Adenovirus mAb (2/6) 50 mg/custom size 3000-5113 - 70 º C 24

Anti-Adenovirus mAb (20/11) 50 mg/custom size 3000-5114 - 70 º C 24

Biomaterials Catalogue 23 Monoclonal Antibodies

Product Description Presentation Reference Storage

Hepatitis B Virus

Anti-HBs mAb (1DE2) 50 mg/custom size* 3000-5012 -70 ºC**

* Packaging available upon request - minimum order 50 mg and minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Clone No. 1DE2. Immunogen source Hepatitis B surface antigen purified from human plasma. Specificity This antibody specifically recognizes Hepatitis B surface antigen, ad and ay subtypes. Antibody source IN VITRO cell culture. Purification Affinity chromatography. Buffer used Citrate 0.1 M pH 5.0 corrected to pH 7.5. Purity ≥ 95% by SDS-PAGE. Antibody isotype Mouse IgG1 kappa. Protein concentration 2-6 mg/ml (A280 x 0.71). Preservative No preservative added.

Adenovirus

Anti-Adenovirus mAb (2/6) 50 mg/custom size* 3000-5113 -70 ºC**

* Packaging available upon request - minimum order 50 mg and minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Clone No. ADV 2/6. Immunogen source Adenovirus 3 infected supernatant culture. Specificity Reacts with all 41 serotypes of Adenoviruses. Antibody source IN VITRO cell culture. Purification Affinity chromatography. Buffer used Citrate 0.1 M pH 5.0 corrected to pH 7.5. Purity ≥ 95% by SDS-PAGE. Antibody isotype Mouse IgG1 kappa. Protein concentration 1-4 mg/ml (A280 x 0.71). Preservative No preservative added.

Anti-Adenovirus mAb (20/11) 50 mg/custom size* 3000-5114 -70 ºC**

* Packaging available upon request - minimum order 50 mg and minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mg. Clone No. ADV 20/11. Immunogen source Adenovirus 3 infected supernatant culture. Specificity Reacts with all 41 serotypes of Adenoviruses. Antibody source IN VITRO cell culture. Purification Affinity chromatography. Buffer used Citrate 0.1 M pH 5.0 corrected to pH 7.5. Purity ≥ 95% by SDS-PAGE. Antibody isotype Mouse IgG1 kappa. Protein concentration 1-4 mg/ml (A280 x 0.71). Preservative No preservative added.

24 Biomaterials Catalogue Sera

Product Description Presentation Reference Storage Page

Anti-HBs Goat Serum 5 mL/vial 3000-5097 - 20 ºC 26

Anti-HBs Rabbit Serum 5 mL/vial 3000-5098 - 20 ºC 26

Anti-Treponema pallidum Rabbit Serum 5 mL/vial 3000-5239 - 20 ºC 26

Anti-Rotavirus Rabbit Serum 5 mL/vial 3000-5096 - 20 ºC 26

Biomaterials Catalogue 25 Sera

Product Description Presentation Reference Storage

Hepatitis B Virus

Anti-HBs Goat Serum 5 mL/vial* 3000-5097 - 20 ºC**

* Packaging available upon request - minimum size 5 ml/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mL. Source Serum of goat hyperimmunized with highly purified nHBsAg (ad +ay). Preservative < 0.1% sodium azide.

Anti-HBs Rabbit Serum 5 mL/vial* 3000-5098 - 20 ºC**

* Packaging available upon request - minimum size 5 ml/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mL. Source Serum of rabbits hyperimmunized with highly purified nHBsAg (ad +ay). Preservative < 0.1% sodium azide.

Treponema pallidum

Anti-Treponema pallidum Rabbit Serum 5 mL/vial* 3000-5239 - 20 ºC**

* Packaging available upon request - minimum size 5 ml/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mL. Source Serum of rabbits hyperimmunized with Treponema pallidum. Preservative < 0.1% sodium azide.

Rotavirus

Anti-Rotavirus Rabbit Serum 5 mL/vial* 3000-5096 - 20 ºC**

* Packaging available upon request - minimum size 5 ml/vial. ** Avoid repeated freezing and thawing.

Specifications Selling unit mL. Source Serum of rabbits hyperimmunized with purified Rotavirus. Preservative < 0.1% sodium azide.

26 Biomaterials Catalogue Under Development

Native Antigens

Helicobacter pylori Antigen

Recombinant Antigens

Recombinant Trypanosoma cruzi FP3 Antigen

Recombinant Trypanosoma cruzi FP6 Antigen

Recombinant Trypanosoma cruzi FP10 Antigen

Biomaterials Catalogue 27 Living Immunoassay Excellence.

Biokit is a biotechnological company aimed at the research, development, manufacture and worldwide distribution of clinical diagnostic reagents and systems.

Biokit’s mission is to become the partner of choice as a Centre of Excellence for Immunoassay by providing innovative OEM solutions (products & services) to major IVD players.

Biokit is strongly founded on three major values: Innovation at all the company levels, always focused on science and technological advances to ensure that our portfolio continuously improves and evolves. Quality in all processes, from the conception of and research on a new product, up to its final manufacturing and marketing. Commitment to patients and healthcare professionals, improving quality of care and facilitating disease diagnosis.

Can Malé 08186 Lliçà d’Amunt Barcelona, Spain Phone: +34-93-860-9000

www.biokit.com 3100-9717 R06 OCT-2017