Independently of the type of cell therapy product or the medical indication, the production of cell-based therapeutics is highly complex.
apceth Biopharma has, therefore, established a robust state-of-the-art production process for cell products, which is fully compliant with all regulatory definitions of the current European ATMP Regulation (EC) No. 1394/2007 as well as covering the general FDA-requirements for biological products.
In 2010 apceth Biopharma (at that time apceth) received a manufacturing license for pharmaceutical production of somatic cell therapeutics and tissue procurement according to §13 and §20b of the German Medicines Act (AMG). It was one of the very first companies in Germany to achieve this status.
Since 2010 the manufacturing license has been expanded to cover multiple new products (ATMPs), including both our own (apceth Biopharma) and customer products, as well as genetically engineered and native cells. To this end, apceth Biopharma has repeatedly and successfully completed a number of inspections by the relevant regulatory authorities (the Bavarian Government and the Paul-Ehrlich-Institute).
In addition, apceth Biopharma’s GMP process and production facilities are subject to regular audits by our clients.
We are able to manufacture any non-embryonic cell type, according to the needs of all our clients, to the highest standards of quality and with adherence to local laws and regulations in Europe and other international regulatory territories.