This article explores the US and EU compliance requirements to ensure patient safety for GMP ancillary materials in cell and gene therapy (CGT) manufacturing.
SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of Good Manufacturing Practices (GMP), cutting-edge, induced pluripotent stem cell (iPSC) technologies, today announced the immediate ...
MINNEAPOLIS, June 8, 2020 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH) today announced the release of GMP ProDots™ Proteins to support cell and gene therapy manufacturing workflows. GMP ...
Expansion Adds U.S. FDA and EU Annex 1 Compliant GMP Capacity with High-Throughput Manufacturing Design and Advanced Automation by Q3 2026. "As more therapies advance to late-stage development, the ...
Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.
Facility expansions and over 5,800 CGT/ATMP batches manufactured underscore Cellex's strength as a trusted full-service CDMO in Europe. COLOGNE, Germany, June 10, 2025 /PRNewswire/ -- Cellex Cell ...
Pluristyx, a leading provider of Good Manufacturing Practices (GMP), cutting-edge, induced pluripotent stem cell (iPSC) technologies, today announced the immediate availability of the PSXi013 iPSC ...
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