Biotech CIP Cycle Development
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
(MBR) Technology for Wastewater Treatment and Reclamation: Membrane Fouling
membranes Review Membrane Bioreactor (MBR) Technology for Wastewater Treatment and Reclamation: Membrane Fouling Oliver Terna Iorhemen *, Rania Ahmed Hamza and Joo Hwa Tay Department of Civil Engineering, University of Calgary, Calgary, AB T2N 1N4, Canada; [email protected] (R.A.H.); [email protected] (J.H.T.) * Correspondence: [email protected]; Tel.: +1-403-714-7451 Academic Editor: Marco Stoller Received: 14 April 2016; Accepted: 12 June 2016; Published: 15 June 2016 Abstract: The membrane bioreactor (MBR) has emerged as an efficient compact technology for municipal and industrial wastewater treatment. The major drawback impeding wider application of MBRs is membrane fouling, which significantly reduces membrane performance and lifespan, resulting in a significant increase in maintenance and operating costs. Finding sustainable membrane fouling mitigation strategies in MBRs has been one of the main concerns over the last two decades. This paper provides an overview of membrane fouling and studies conducted to identify mitigating strategies for fouling in MBRs. Classes of foulants, including biofoulants, organic foulants and inorganic foulants, as well as factors influencing membrane fouling are outlined. Recent research attempts on fouling control, including addition of coagulants and adsorbents, combination of aerobic granulation with MBRs, introduction of granular materials with air scouring in the MBR tank, and quorum quenching are presented. The addition of coagulants and adsorbents shows a significant membrane fouling reduction, but further research is needed to establish optimum dosages of the various coagulants/adsorbents. Similarly, the integration of aerobic granulation with MBRs, which targets biofoulants and organic foulants, shows outstanding filtration performance and a significant reduction in fouling rate, as well as excellent nutrients removal. -
Biopharma PAT Quality Attributes, Critical Process Parameters & Key
Biopharma PAT Quality Attributes, Critical Process Parameters & Key Performance Indicators at the Bioreactor May 2018 White Paper: Biopharma PAT Quality Attributes, Critical Process Parameters & Key Performance Indicators at the Bioreactor Table of Contents PAT Building Blocks .................................................................................................... 3 PAT for Biopharma ...................................................................................................... 5 Culture & Fermentation Process Types ....................................................................... 6 Monitoring Methods .................................................................................................... 8 Critical Process Parameters ...................................................................................... 10 Critical Quality Attributes & Key Performance Indicators ........................................... 14 Recent Applications of In-situ VCD & TCD ................................................................ 17 Conclusions .............................................................................................................. 19 References ................................................................................................................ 20 Focus Spots Intelligent Arc Sensors for pH and DO in-situ Measurement...................................... 10 Dissolved Oxygen User’s Experiences ...................................................................... 11 In-situ Cell Density -
Drug Delivery Technology Y
* DDT Nov-Dec 2007 Working 11/9/07 2:29 PM Page 1 November/December 2007 Vol 7 No 10 IN THIS ISSUE Company Profiles 12 Drug Delivery Technologies 58 Excipients, Polymers, Liposomes & Lipids 78 Contract Pharmaceutical & Biological Development Services 83 Machinery & Laboratory Equipment and Software 96 Technology Showcase 102 The science & business of specialty pharma, biotechnology, and drug delivery www.drugdeliverytech.com * DDT Nov-Dec 2007 Working 11/9/07 2:39 PM Page 2 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 3 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 4 November/December 2007 Vol 7 No 10 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Coming in 2008 Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Drug Delivery Weekly & Fax: (703) 548-3733 E-mail: [email protected] Specialty Pharma News E-mail: [email protected] West Coast Warren De Graff Western Regional Manager 818 5th Avenue, Suite 301 San Rafael, CA 94901 Tel: (415) 721-0644 Fax: (415) 721-0665 E-mail: [email protected] 0 The weekly electronic newsletter from the publishers of Drug 1 International o N Delivery Technology and Specialty Pharma will provide over 12,000 Ralph Vitaro 7 219 Changebridge Road l o subscribers with the latest news of business deals, alliances, and V Montville, NJ 07045 Tel: (973) 299-1200 7 technology breakthroughs from the pharmaceutical, specialty 0 Fax: (973) 299-7937 0 2 pharmaceutical, drug delivery, and biotechnology industries. -
Progress Report January 2009 – December 2011
North Carolina State University Professional Science Master’s Program Progress Report January 2009 – December 2011 The Graduate School College of Agriculture & Life Sciences College of Design College of Education College of Engineering College of Humanities & Social Sciences Poole College of Management College of Natural Resources College of Physical & Mathematical Sciences College of Textiles College of Veterinary Medicine First-Year College 1 Greetings From the UNC System PSM Director The Professional Science Master’s (PSM) Program is one of the University of North Carolina (UNC) System’s ways to close the existing skills gap in the workplace. Together with local employers, we design graduate education and training regimens to match employers’ needs. The UNC System has undertaken a collaborative effort to develop these new programs in key areas of importance to North Carolina’s local economies. I am pleased to report that NC State University now offers nine PSM programs. Several new programs are at various planning stages, and numerous new central resources and services are available or under way for these programs. A special milestone in 2010 was the establishment of the PSM Council at NC State University. Members of this group include faculty who direct PSM programs or are planning to offer them in the future. The PSM Council oversees new program development and determines the future strategy for the PSM programs at NC State University. Another important milestone was the award of a new UNC System grant from the Alfred P. Sloan Foundation and support from the UNC General Administration for multiple online tools. I am greatly indebted to the many employers, professors and students who contribute to the collective success of NC State University’s PSM programs. -
Stachytarpheta Cayennensis Aqueous Extract, a New Bioreactor Towards Silver Nanoparticles for Biomedical Applications
Journal of Biomaterials and Nanobiotechnology, 2019, 10, 102-119 http://www.scirp.org/journal/jbnb ISSN Online: 2158-7043 ISSN Print: 2158-7027 Stachytarpheta cayennensis Aqueous Extract, a New Bioreactor towards Silver Nanoparticles for Biomedical Applications Francois Eya’ane Meva1,2* , Joel Olivier Avom Mbeng1, Cecile Okalla Ebongue1,3, Carsten Schlüsener2, Ülkü Kökҫam-Demir2, Agnes Antoinette Ntoumba4, Phillipe Belle Ebanda Kedi4, Etienne Elanga1, Evrard-Rudy Njike Loudang1, Moise Henri Julien Nko’o1, Edmond Tchoumbi1, Vandi Deli1, Christian Chick Nanga1, Emmanuel Albert Mpondo Mpondo1, Christoph Janiak2 1Department of Pharmaceutical Sciences, Faculty of Medicine and Pharmaceutical Sciences, University of Douala, Douala, Cameroon 2Institute for Inorganic Chemistry and Structural Chemistry, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany 3Clinical Biology Laboratory, General Hospital of Douala, Douala, Cameroon 4Department of Animal Biology and Physiology, Faculty of Science, University of Douala, Douala, Cameroon How to cite this paper: Meva, F.E., Abstract Mbeng, J.O.A., Ebongue, C.O., Schlüsener, C., Kökҫam-Demir, Ü., Ntoumba, A.A., Kedi, This study reports the preparation and characterization of silver nanopar- P.B.E., Elanga, E., Loudang, E.-R.N., Nko’o, ticles synthesized by the mediation of the plant weed Stachytarpheta cayen- M.H.J., Tchoumbi, E., Deli, V., Nanga, C.C., nensis through solution method. Ultraviolet visible spectroscopy (UV-Vis) Mpondo, E.A.M. and Janiak, C. (2019) Sta- chytarpheta cayennensis Aqueous Extract, a determines the presence of nanoparticles in the solution. Infrared spectros- New Bioreactor towards Silver Nanopar- copy (IR) proves organic molecules at the particles interface. Powder X-ray ticles for Biomedical Applications. Journal diffraction (PXRD) provides phase composition and crystallinity. -
Bioreactor Studies of Heterologous Protein Production by Recombinant Yeast
BIOREACTOR STUDIES OF HETEROLOGOUS PROTEIN PRODUCTION BY RECOMBINANT YEAST by ZHIGEN ZWNG A thesis presented to the University of Waterloo in fulNlment of the thesis quinment for the degree of Doctor of Philosophy in Chernical Engineering Waterloo, Ontario, Canada, 1997 @ Zhigen Zhang 1997 National tibrary Bibliothi?que nationale l*l dm, du Canada Acquisitions and Acquisitions et Bibliographie Services seMces bubriographiques 395 wellaStreet 395, me wdtingtori OrtawaON KIAW ûtiawaOlJ K1AûN4 Canada Canada Va#& Voinciilline, avm Nom- The author has pteda non- L'auteur a accordé une licence non exclusive licence dowiug the exclwe permettant il Ia National Ijiiiof Canada to Bibliothèque nationale du Cadade reproduce, 10- disttibute or sell reprodnire, *, distn'buerou copies of bis/her thesis by any means vendre des copies de sa thése de and in any fonn or fomLaf making qyelqy manière et sous quelque this thesis avaiiable to interested forme que ce soit pour mettre des persofls- exemplaires de cette thèse à la disposition des persornes intéressées. The auîhor retains owndpof the L'auteur conserve la propriété du copyright m Merthesis. Neither droit d'auteur qui protège sa thèse. Ni the thesis nor substsmtial extracts la thèse ni &s extmits substantiels de fiom it may be printed or otherwiSe celleci ne doivent être imprimés ou reproduced with the author's autrement reproduits sans son permission. autorisalian, nie University of Waterloo requin% the signatures of ali pesons using or photocopying this thesis. Please sign below. and give address and dite. ABSTRACT Fundamend enginee~gstudies were carried out on heterologous protein production using a recombinant Saccharomyces cerevisiae sPain (C468fpGAC9) which expresses Aspergillus mamon glucoamylase gene and secretes glucoamylase into the extracellular medium, as a model system. -
PIIS0016508516348168(1).Pdf
Gastroenterology 2016;151:651–659 CLINICAL—LIVER High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis Edward Gane,1 Fred Poordad,2 Stanley Wang,3 Armen Asatryan,3 Paul Y. Kwo,4 Jacob Lalezari,5 David L. Wyles,6 Tarek Hassanein,7 Humberto Aguilar,8 Benedict Maliakkal,9 Ran Liu,3 Chih-Wei Lin,3 Teresa I. Ng,3 Jens Kort,3 and Federico J. Mensa3 1University of Auckland, Auckland, New Zealand; 2Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas; 3AbbVie, Inc, North Chicago, Illinois; 4Indiana University School of Medicine, Indianapolis, Indiana; 5Quest Clinical Research, San Francisco, California; 6University of California San Diego, La Jolla, California; 7Southern California GI and Liver Centers and Southern California Research Center, Coronado, California; 8Louisiana Research Center, Shreveport, Louisiana; 9University of Rochester Medical Center, Rochester, New York to liver decompensation, as defined by ascites, jaundice, See Covering the Cover synopsis on page 571; encephalopathy, or variceal bleeding.2 Achievement of a CLINICAL LIVER see editorial on page 587. sustained virologic response (SVR) reduces the risk of hepatic decompensation events, end-stage liver disease, 3–5 BACKGROUND & AIMS: The combination of ABT-493 (NS3/4A hepatocellular carcinoma, and liver-related mortality. protease inhibitor) plus ABT-530 (NS5A inhibitor) has shown Recognizing the need to prevent these complications, the high rates of sustained virologic response at post-treatment American Association for the study of Liver Diseases/ week 12 (SVR12) in noncirrhotic patients infected with hepa- Infectious Disease Society of America, and the European titis C virus (HCV) genotypes (GTs) 1–6. -
Radius Health, Inc
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive Proxy Statement ☐ Definitive Additional Materials ☐ Soliciting Material Pursuant to §240.14a-12 RADIUS HEALTH, INC. (Name of Registrant as Specified in its Charter) (Name of Person(s) Filing Proxy Statement, if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box): ☒ No fee required. ☐ Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. (1) Title of each class of securities to which transaction applies: (2) Aggregate number of securities to which transaction applies: (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): (4) Proposed maximum aggregate value of transaction: (5) Total fee paid: ☐ Fee paid previously with preliminary materials: ☐ Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount previously paid: (2) Form, Schedule or Registration Statement No.: (3) Filing Party: (4) Date Filed: April 20, 2018 To Our Stockholders: You are cordially invited to attend the 2018 Annual Meeting of Stockholders of Radius Health, Inc. -
4Oct200722045121 1Dec200517045043
4OCT200722045121 This prospectus (the ‘‘Prospectus’’) relates to the initial offering (the ‘‘Offering’’) to subscribe for up to A75 million of new common shares in Ablynx NV (the ‘‘Company’’ or ‘‘Ablynx’’), with VVPR strips (the ‘‘VVPR Strips’’). This amount of New Shares with VVPR Strips may be increased by up to 15 per cent, to an amount of A86.25 million (the ‘‘Increase Option’’, the new shares initially offered and the shares offered as a result of the possible exercise of the Increase Option jointly being referred to as the ‘‘New Shares’’). Any decision to exercise the Increase Option will be announced, at the latest, on the date the Offer Price is announced. JPMorgan and KBC Securities (the ‘‘Joint Global Coordinators’’) will be granted an over-allotment option by the Company (the ‘‘Over-allotment Option’’), exercisable as of the listing date (the ‘‘Listing Date’’) and until 30 days thereafter, corresponding to up to 15 per cent of the New Shares subscribed for in the Offering for the sole purpose of allowing the Joint Global Coordinators to cover over-allotments, if any. The existing shares covered by the Over-allotment Option (the ‘‘Additional Shares’’ and, together with the New Shares, the ‘‘Offered Shares’’) and the New Shares issued upon exercise of the Over-allotment Option, if any, will not have a separate VVPR Strip. The Offered Shares are offered to the public in Belgium (including to employees, consultants and independent directors of the Company in Belgium) and, pursuant to a private placement, to institutional investors, both within and outside Belgium and to employees, consultants and independent directors of the Company outside Belgium. -
Life Sciences Industry Wake County * Research Triangle Index of Featured Organizations Contract Research Contract Manufacturer 48
LIFE SCIENCES INDUSTRY WAKE COUNTY * RESEARCH TRIANGLE INDEX OF FEATURED ORGANIZATIONS Contract Research Contract Manufacturer 48. Kurve Technology, Inc. ...............................D4 49. LaamScience, Inc. ...............................C4, I10 1. A10 Clinical Solutions, Inc. ........................E5 71. Accurate Machine and Tool Co. .................E8 50. LipoScience, Inc. ........................................C7 2. AAIPharma, Inc....................................C4, I11 72. Better Medicines, LLC ................................C3 51. Mardil, Inc. ..................................................D4 3. Alpha-Gamma Technologies, Inc. ..............D7 73. Merck BioManufacturing Network .............D4 52. MDxHealth, Inc. ................................... B3, G9 4. Analytical Solutions, Inc. ..................... C3, H9 74. Nortech Systems 53. Med-El Corp. ..................................... B3, G10 5. Appealing Products, Inc. ............................E6 (Formally TriVirix International) ..................A3 54. MedFaxx, Inc. .............................................A8 6. BIoCI Systems, Inc. ....................................D8 75. Patheon, Inc. .......................................C4, I11 55. Medisim USA .............................................. F5 7. BioLink Life Sciences, Inc. .........................D4 76. Rockwell Automation Life Sciences ...........E4 56. Medis Medical Imaging Systems, Inc. ........C7 8. Burleson Research Technologies ..............C4 77. Stainless Steel Fabrications .......................D7 -
Guide to Biotechnology 2008
guide to biotechnology 2008 research & development health bioethics innovate industrial & environmental food & agriculture biodefense Biotechnology Industry Organization 1201 Maryland Avenue, SW imagine Suite 900 Washington, DC 20024 intellectual property 202.962.9200 (phone) 202.488.6301 (fax) bio.org inform bio.org The Guide to Biotechnology is compiled by the Biotechnology Industry Organization (BIO) Editors Roxanna Guilford-Blake Debbie Strickland Contributors BIO Staff table of Contents Biotechnology: A Collection of Technologies 1 Regenerative Medicine ................................................. 36 What Is Biotechnology? .................................................. 1 Vaccines ....................................................................... 37 Cells and Biological Molecules ........................................ 1 Plant-Made Pharmaceuticals ........................................ 37 Therapeutic Development Overview .............................. 38 Biotechnology Industry Facts 2 Market Capitalization, 1994–2006 .................................. 3 Agricultural Production Applications 41 U.S. Biotech Industry Statistics: 1995–2006 ................... 3 Crop Biotechnology ...................................................... 41 U.S. Public Companies by Region, 2006 ........................ 4 Forest Biotechnology .................................................... 44 Total Financing, 1998–2007 (in billions of U.S. dollars) .... 4 Animal Biotechnology ................................................... 45 Biotech -
Download the Pdf Here
Address correspondence to: Early Clearance of HCV RNA in HCV Genotype 1 Treatment-naïve Patients Treated with Telaprevir, Peginterferon and Ribavirin: Kenneth E. Sherman, MD, PhD. 957 Division of Digestive Diseases, University of Pooled Analysis of the Phase 3 Trials ADVANCE and ILLUMINATE Cincinnati College of Medicine, Cincinnati, OH KE Sherman1, GT Everson2, IM Jacobson3, AM Di Bisceglie4, DR Nelson5, L Bengtsson6, N Adda6, RS Kauffman6, CI Wright6, and S Zeuzem7 Email: [email protected] 1University of Cincinnati College of Medicine, Cincinnati, OH, USA; 2University of Colorado Denver, Aurora, CO, USA; 3Weill Cornell Medical College, New York, NY, USA; 4Saint Louis University School of Medicine, Saint Louis, MO, USA; 5University of Florida, Gainesville, FL, USA; 6Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA; 7Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany. Patient Population ABSTRACT Figure 2: Patients with Undetectable HCV RNA over Time Figure 5: Patients who Achieved SVR According to Week 1, Week 2, or Week 4 SUMMARY AND CONCLUSIONS • Treatment-naïve patients infected with genotype 1 chronic HCV were enrolled: HCV RNA Undetectability • Background: Phase 3 trials have demonstrated that addition of telaprevir to currently approved regimens containing – 123 centers in North America, Europe, Argentina, Australia and Israel in ADVANCE peginterferon alfa and ribavirin significantly increased treatment response rates and permitted the majority of patients (A) (B) • More patients were undetectable for HCV RNA at early timepoints (pts) to shorten treatment duration to 24 wks. – 74 centers in the United States and Europe in ILLUMINATE Week 1 Undetectable Week 2 Undetectable Week 4 Undetectable 100 100 when treated with a telaprevir-based regimen.