DOWNSTREAM PROCESSING FEATURED ARTICLES
Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, recently announced the initiation of a phase 2 study of its novel, investigational protein therapeutic, ACE-536, to treat patients with beta-thalassemia, a genetic hematologic disorder causing chronic and life-threatening anemia and serious complications affecting the spleen, liver and heart.
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A Welcome Predictability
Synthetic biology is the latest and most advanced phase of genetic engineering, holding great promise for helping to solve some of the world's most intractable problems, including the sustainable production of energy fuels and critical medical drugs, and the safe removal of toxic and radioactive waste from the environment.
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BioPharma Industry Getting Comfortable With Complex Single-Use Devices
The rate of usage of disposables in biopharmaceutical manufacturing has increased substantially over the past six years in a variety of areas, but most notably for complex devices, that are also among the most expensive. By Eric Langer
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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.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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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Biomanufacturing Flexibility
This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.
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![Fig 1]( "Cultivation Of CHO Suspension Cells And SEAP Expression")
Cultivation Of CHO Suspension Cells And SEAP ExpressionThis application note describes the cultivation of CHO suspension cells in the wave-mixed Thermo Scientific HyPerforma Rocker Bioreactor with a maximum working volume of 5 L.
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![Test tubes laboratory GettyImages-1310126023]( "Examining Column Reproducibility During Method Development In Clinical Labs")
Examining Column Reproducibility During Method Development In Clinical LabsIn this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.
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White Paper: Capillary Electrophoresis — A Simple Technique
In 1989, Beckman Instruments introduced the first fully automated capillary electrophoresis instrument (P/ACE™ 2000) to the scientific community. At that time, CE demonstrated exceptional resolving of selected compounds, but the new technology lacked a track record of applications. By Beckman Coulter, Inc.
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Efficiency Test Of ReadyToProcess™ Columns
ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).
DOWNSTREAM PROCESSING PRODUCTS
Sartopure PP2 Cartridges were optimized for the wide range of prefiltration.
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.