apceth has announced the successful conclusion of a major GMP inspection that reinforces apceth's position as one for the worldwide leading developers and GMP manufacturers of cell and gene therapy products. The GMP inspection was conducted by the Bavarian State Authorities and the Germany regulatory agency Paul-Ehrlich-Institute (PEI).
The subject of the inspection were two innovative medicinal products, which are now included in apceth's GMP manufacturing license according to §13 of the German Medicines Act (AMG).
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.
In addition, two new GMP cleanrooms for aseptic processing were 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 GMP facilities.
“This is a very positive development for apceth, one more step in the continuous expansion of our GMP services business and reflects our enduring success in the space. The expansion will ensure that we remain one step ahead of the manufacturing capacity demands of our current and new clients, as well as for our own therapeutic pipeline”, said Ulrike Verzetnitsch, apceth CTO and former Director of Production at Baxter and Takeda.
Verzetnitsch continued, “It is also testament to the expansion of our pipeline of next-generation cell therapies and the efficiency of our non-clinical and pharmaceutical development teams”, she added.