This article explores the US and EU compliance requirements to ensure patient safety for GMP ancillary materials in cell and ...

NEW YORK, Sept. 3, 2025 /PRNewswire/ -- Rising adoption of cell and gene therapies, along with increasing investments in biopharmaceutical R&D, is accelerating demand for GMP-grade consumables ...

SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of Good Manufacturing Practices (GMP), cutting-edge, induced pluripotent stem cell (iPSC) technologies, today announced the immediate ...

MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)--Cellistic®, a pioneer in iPSC-based off-the-shelf cell therapy development and manufacturing, announces the successful audit and GMP certification of its ...

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.

Buffalo, N.Y.-based Roswell Park Comprehensive Cancer Center opened a $98 million cell and gene therapy hub aimed at growing the center’s capabilities for cancer cell therapy research. The Roswell ...

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 ...