DOWNSTREAM PROCESSING FEATURED ARTICLES
Top representatives from the healthcare industry are confirmed to attend the 2nd Biosimilars Congregation which will take place in London on the 19th and 20th of February 2013. Ranjith Gopinathan, Frost & Sullivan Program Manager for Life Sciences, Europe Practice is set to participate to the event’s Keynote Panel Discussion focusing on challenges and opportunities in the global biosimilars market.
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Ablynx's Anti-IL-6R Nanobody, ALX-0061, Shows Excellent 24 Week Safety And Efficacy Results In A Phase II Clinical Trial In Rheumatoid Arthritis
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
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FDA Reports Conditions Observed At New England Compounding Center Facility
Recently, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
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Battelle Develops Transgenic Plant Protein Production Platform If your company is looking for plant-based protein sources, look into a new transgenic tobacco from Battelle’s Pacific Northwest Laboratory...
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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USP <787> Small Volume Testing With Liquid Particle Counters
By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.
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Connection Technology Advances Closed System Processing
The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company
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White Paper: Computrac® Moisture Analysis Made Simple When people aren’t feeling their best they often turn to medicine for relief from the symptoms that are associated with being ill. The public trusts that the products by pharmaceutical companies will not only make them feel better but will also not have harmful side effects.
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Automated Bioluminescent ADCC Reporter Bioassay Using Bioengineered Jurkat Cells
Pharmaceutical companies are increasingly exploring new biologic and biosimilar products, and thus increasing monoclonal antibody (mAb) immunotherapeutic research. By Tracy Worzella, Promega Corporation and Brad Larson, Applications Department, BioTek Instruments, Inc.
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Biomanufacturing Debottlenecking And Process Optimization
Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G
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Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media
Monoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).