DOWNSTREAM PROCESSING FEATURED ARTICLES
Standardized Extractables Testing Advances Single Use Adoption
The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.
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Diabetes Research Reveals Important Link To Overcoming 'Lazy Insulin Granules'
Scientists at Toronto Western Research Institute have made an important discovery on the role of a SNARE protein known as VAMP8 in the release of insulin from the pancreatic islet beta cells.
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![Markus-Grompe_01TN_1]( "OHSU Doernbecher Scientists First To Grow Liver Stem Cells In Culture, Transplant Them With Demonstrated Therapeutic Benefit")
OHSU Doernbecher Scientists First To Grow Liver Stem Cells In Culture, Transplant Them With Demonstrated Therapeutic BenefitFor decades scientists around the world have attempted to regenerate primary liver cells known as hepatocytes because of their numerous biomedical applications, including hepatitis research, drug metabolism and toxicity studies, as well as transplantation for cirrhosis and other chronic liver conditions.
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![Phenomenex Kinetex Calculator]( "Next-Generation Kinetex Calculator From Phenomenex Customizes Core-Shell HPLC/UHPLC Method Creation")
Next-Generation Kinetex Calculator From Phenomenex Customizes Core-Shell HPLC/UHPLC Method Creation Phenomenex Inc., a global leader in the research and manufacture of advanced technologies for the separation sciences, introduces the next-generation Kinetex Calculator – an online tool that generates customized, optimized Kinetex methods for HPLC or UHPLC systems.
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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Metal Removal From Fine Chemical Products
Metal contamination in various injectable or even oral medicines is a serious concern.
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Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action
Gemin X, a pharmaceutical company focused on the discovery and development of advanced oncology
therapeutics, approached Metabolon to run a metabolism profile for one of their compounds—GMX1777. -
Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers
Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager
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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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![Bulletin_5825Photo.jpg]( "Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media")
Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite MediaCHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.
DOWNSTREAM PROCESSING PRODUCTS
CHT is a leading purification medium of biomolecules in today’s demanding downstream process industry. Its mixed-mode support offers unique selectivities and often separates biomolecules that appear homogeneous with other chromatographic methods. The diverse binding capabilities of CHT for host cell proteins, leached protein A, antibody dimers and aggregates, nucleic acids, and viruses allow its use at any stage from initial capture to final polishing.
Resin are designed specifically for intermediate purification steps that remove host-cell contaminants from partially purified targets using strong or weak hydrophobic interactions. Methacrylate-based beads for protein and nucleic acid purification using hydrophobic interactions are available for purifying compounds that have weak or strong hydrophobic regions.
Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.
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.