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.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Hesperos, Psilera Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia
June 9th 2025The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
