The expansion will now see the company with manufacturing capacity of 600 m2. The GMP inspection was conducted by the Bavarian State Authorities and the German regulatory agency Paul-Ehrlich-Institute (PEI).
The subject of the inspection was two products, which are now included in Apceth's GMP manufacturing license. The first is Agenmestencel-L, apceth's allogeneic genetically modified mesenchymal stem cells (gmMSCs) for solid cancer. The second product is a genetically modified ATMP (advanced-therapy medicinal product) that Apceth is manufacturing at clinical GMP grade for an unnamed client.
“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.