apceth uses its production and quality management system to offer contract GMP-manufacturing, product co-development and associated services such as GMP and regulatory consulting for cell-based products.
With its GMP services apceth can support the development and commercialization of the clinical grade cell products for partners and customers. apceth guarantees a robust manufacturing process and an exceptional and consistent batch-to-batch quality of every cell product.
By providing cell products of the highest quality apceth will assist you in translation of your research into clinical application in the shortest time possible.
apceth provides following GMP contract services
- (Co)development of ATMPs
- GMP manufacturing of ATMPs
- ATMP quality control (identity, purity, potency, sterility, genetic stability)
- Quality management
- Quality assurance
- Release of ATMPs by Qualified Persons
- Upscaling of cells & cell products
- Cryopreservation & cell banking
- Storage & distribution of ATMPs
- Reconstitution & application of ATMPs
- ATMP regulatory consulting & service
- EU import & commissioning of ATMPs