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apceth Expands GMP Manufacturing Capabilities with Addition of Two Cell and Gene Therapy Products
PTSM: Pharmaceutical Technology Sourcing and Management
apceth has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG).
Clinical-stage biopharmaceutical company, apceth announced that it has completed a major GMP inspection for two medicinal products. The two cell and gene therapy products are now included in the company’s GMP manufacturing license according to §13 of the German Medicines Act (AMG). The GMP inspection was conducted by the Bavarian State Authorities and the Germany regulatory agency Paul-Ehrlich-Institute (PEI).
The first product is Agenmestencel-L, apceth's allogeneic next generation genetically modified mesenchymal stem cells (gmMSCs) for solid cancer. This successful GMP certification of the production process represents a crucial milestone in the development of apceth's allogeneic off-the-shelf product. The second product is a genetically modified ATMP product that apceth is manufacturing at clinical GMP grade for a client.
Two new GMP cleanrooms for aseptic processing were also approved and will be used for handling and genetic manipulation of various types of cell and gene therapeutics. The addition further extends the manufacturing capacity of apceth's 600 m2 state-of-the-art GMP facilities.