DOWNSTREAM PROCESSING FEATURED ARTICLES
Repligen Corporation announced recently that it has acquired the business of Refine Technology (“Refine”), including Refine’s Alternating Tangential Flow (“ATF”) System, a market-leading device used to significantly increase product yield during the fermentation step of the biologic drug manufacturing process.
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Thermo Fisher Scientific Introduces Data System To Unite Chromatography And Mass Spectrometry
Thermo Fisher Scientific Inc., the world leader in serving science, recently introduced the next generation of its gold-standard Chromeleon chromatography data system (CDS), which now supports mass spectrometry along with mainstream front-end separation techniques in the same software package.
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Hamilton Robotics Launches Highly Flexible PCR Setup Workstation
Hamilton Robotics introduces the PCR setup STARlet, the first automated liquid handling system flexible enough to accommodate any DNA amplification reagent kit, from simple setups and small budgets to highly demanding workflows.
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Novavax Initiates Phase 2 Clinical Trial Of RSV Vaccine Candidate
Novavax, Inc. today announced that enrollment has begun in a Phase 2 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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CD69 Expression On Activated Lymphocytes Is Stable In Streck's Cyto-Chex® BCT
The purpose of this study was to determine if the activation marker, CD69, is preserved and stable in whole blood samples collected in Cyto-Chex® BCT. Previous studies have demonstrated CD marker stability of whole blood samples collected in Cyto-Chex BCT for up to 7 days when stored at room temperature (18-22°C). By Jodi Alt, Ph.D
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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).
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Sani-Tech® Ultra White Paper
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.
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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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Metal Removal From Fine Chemical Products
Metal contamination in various injectable or even oral medicines is a serious concern.
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Accelerating Biopharmaceutical Development From DNA To Drug
In the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.