FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...
Small biotechs in early development of cell therapies are often surprised by the strictness of commercial manufacturing standards. That’s the view of Luděk Sojka, PhD, CEO of contract developer and ...
Food safety has been regulated across the world for as long as large-scale food production has been in place – since the mid-1800s in the United States, for example. Resulting from a long history of ...
MINNEAPOLIS, Nov. 3, 2021 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced the commercial availability of GMP-grade materials manufactured at its St. Paul, MN GMP (Good ...
SHANGHAI, June 24, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG17 drug substance ...
Exogenus Therapeutics Taps Lonza to Develop a GMP-Compliant Process for Lead Exosome-Based Candidate
Exogenus Therapeutics and Lonza agreed to collaborate on the development of Exo-101, Exogenus’ exosome-based lead candidate. The company specializes in the development of therapeutics based on ...
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using ...
Sustainable bioprocessing filtration has moved from an aspirational goal to an operational priority as the scale and cost of water, buffer, and solvent consumption in biopharma manufacturing come ...
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