DOWNSTREAM PROCESSING FEATURED ARTICLES
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection.
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Saint-Gobain's New C-Flex® ULTRA Pump Tubing For Biopharmaceutical Applications Outperforms The Competition
Saint-Gobain Performance Plastics has expanded its line of thermoplastic elastomer (TPE) tubing with the addition of new C-Flex® ULTRA pump tubing, a product designed specifically to perform in demanding biopharmaceutical applications such as pumping, single-use assemblies, process filling and sampling.
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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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Selexys Pharmaceuticals Completes $23M Equity Financing And Signs Agreement With Global Pharmaceutical Company
Selexys Pharmaceuticals, Corp., announced today that it has successfully completed a $23 million Series A equity financing, led by MPM Capital. Additionally, Selexys entered into an agreement with Novartis Pharmaceuticals whereby Novartis has been granted an exclusive option to acquire Selexys and its lead asset, the anti-P-selectin antibody SelG1, following the successful completion of a Phase 2 clinical study in patients with sickle cell disease.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes
Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.
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Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
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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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White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
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![FiT_MaxiCaps-_20158]( "Accelerating Biopharmaceutical Development From DNA To Drug")
Accelerating Biopharmaceutical Development From DNA To DrugIn 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.
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![XDR-50MO]( "Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System")
Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor SystemThis application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
DOWNSTREAM PROCESSING PRODUCTS
A wide selection of ion exchange resin is available in various particle sizes, ionic forms, and purity ranges to offer a variety of purification solutions for process applications. Nuvia ion exchange resins are a family of best-in-class ion exchangers built with exceptionally high capacities and excellent purification capabilities, providing process developers more flexibility and higher productivity. The Macro-Prep are rigid macroporous hydrophilic resin meet the demands of process-scale applications. Chemically and mechanically stable, the resin operate well at low and medium pressures.
A proven method for confirming protein purity and yield without the need for gel staining steps. Stain-free gels provide visual confirmation of protein purity and yield by gel electrophoresis in less than 30 minutes. Stain-free technology is perfect for drug discovery, drug development, and method development for preclinical research.
Macro-Prep hydrophobic interaction chromatography (HIC) media are methacrylate-based, 50 µm beads used for protein, polypeptide, enzyme, and nucleic acid purification.
Another proven method for cGMP processing is also available now using drums, a conical drum funnel and drum lifts.
Nuvia HR-S media is a new strong cation exchanger that has been optimized for particle size and chemistry that provides exceptional resolution and high recovery.
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.