DOWNSTREAM PROCESSING FEATURED ARTICLES
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FDA Reports Conditions Observed At New England Compounding Center Facility
Recently, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
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![121107_monuki_c228px.jpg]( "New Cell Type Developed For Possible Treatment Of Alzheimer's And Other Brain Diseases")
New Cell Type Developed For Possible Treatment Of Alzheimer's And Other Brain DiseasesUC Irvine researchers have created a new stem cell-derived cell type with unique promise for treating neurodegenerative diseases such as Alzheimer’s.
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The Medicines Company And Bristol-Myers Squibb Begin Global Alliance For Recothrom®
The Medicines Company (NASDAQ: MDCO) announced today that the global license and two-year collaboration for Recothrom®, a recombinant thrombin approved by the U.S.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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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![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.
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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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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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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. -
![Determination Of kLa Values Of Single-Use Bioreactors]( "Determination Of kLa Values Of Single-Use Bioreactors")
Determination Of kLa Values Of Single-Use BioreactorsBecause single use bioreactors offered by manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.
DOWNSTREAM PROCESSING PRODUCTS
Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.
ÄKTA avant™ is a preparative chromatography system designed for fast and secure development of scalable methods and processes.
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.