apceth's GMP licence extends to cover new cell and gene therapies
A major GMP inspection has successfully concluded for apceth's production facilities. 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. The successful GMP certification of the production process represents a crucial milestone in the development of this 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 state-of-the-art GMP facilities.
Ulrike Verzetnitsch, apceth CTO and former director of production at Baxter and Takeda, said: “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. 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."