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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New Cell Type Developed For Possible Treatment Of Alzheimer's And Other Brain Diseases
UC 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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Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media
CHT 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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Connection Technology Advances Closed System Processing
The 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
Because 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.