DOWNSTREAM PROCESSING FEATURED ARTICLES
Mayo Clinic researchers have successfully used smaller, folded DNA molecules to stimulate regeneration and repair of nerve coatings in mice that mimic multiple sclerosis (MS). They say the finding, published today in the journal PLoS ONE, suggests new possible therapies for MS patients.
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Skystar's New Vaccine Facility In Huxian Passes Initial GMP Certification
Skystar Bio-Pharmaceutical Company (NASDAQ: SKBI) ("Skystar" or the "Company"), a China-based manufacturer and distributor of veterinary medicines, vaccines, micro-organisms and feed additives, today announced that China's Ministry of Agriculture (MOA) Good Manufacturing Process "GMP" experts have certified that Skystar's new vaccine facility in Huxian, China is 'Stage 1' GMP compliant.
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Boehringer Ingelheim Implements Flexible Fully Disposable Up- And Downstream Manufacturing For Biopharmaceuticals
Boehringer Ingelheim has developed and now implemented a flexible set-up and operational approach for disposable technologies within its global biopharmaceutical development and manufacturing network.
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Taiho Pharmaceutical Announces Start Of Global Phase III Clinical Trial In Metastatic Colorectal Cancer With Novel Antitumor Agent TAS-102
Taiho Pharmaceutical Co., Ltd. announced on May 31 that a global Phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 will start in June this year.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks
Mixed mode resins can serve as an alternative to protein A in intermediate processing. Implementation of mixed mode resins can reduce water required for filtration and time for column loading.
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![CPCBiioprocessing]( "Connection Technology Advances Closed System Processing")
Connection Technology Advances Closed System ProcessingThe 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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Automation Of A Homogeneous Proximity Assay For Detection Of Residual Protein A In Biological Therapeutics
Protein A is used in affinity chromatography for therapeutic antibody purification and has been shown to leach from columns during purification of antibodies resulting in contamination. Residual Protein A in therapeutic drugs could elicit mitogenic or immunological reactions in patients.
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The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems
Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.
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Biological Contamination Events In Isolators: What Lessons Can Be Learned?
Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director
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Global Biochemical Profiling For Bioprocess Optimization
It is widely understood that the production phase of bioprocessing can have a significant impact on the overall profitability of the biopharmaceutical.
DOWNSTREAM PROCESSING PRODUCTS
Macro-Prep hydrophobic interaction chromatography (HIC) media are methacrylate-based, 50 µm beads used for protein, polypeptide, enzyme, and nucleic acid purification.
DOWNSTREAM PROCESSING MULTIMEDIA
Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.
Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.