REGULATORY COMPLIANCE


apceth Biopharma holds licenses for different types of complex cell and gene therapy products falling under the EU definition of Advanced Therapy Medicinal Products (ATMPs, European ATMP regulation (EC) No.1394/2007). These include both native and genetically engineered cells and cell-based products.

In 2010, our GMP process for ATMPs and our production facilities were first certified by the relevant Bavarian and German authorities. With this certification, apceth Biopharma became one of the first companies in Germany with a GMP manufacturing license for ATMPs. The GMP license is accompanied by the certified BSL2 status. This unique GMP/BSL2 combination allows us to handle and produce genetically modified cells and viral vectors.

Since 2010, our manufacturing processes and our facilities have been subject to regular inspections by the relevant authorities (the Bavarian Government and the Paul-Ehrlich-Institute). Through these further inspections, we have obtained manufacturing licenses for a number of our own products as well as for products developed on behalf of clients. The inspections are complemented by external audits performed by apceth Biopharma clients.

For every new client product, apceth Biopharma establishes a robust, state-of-the-art production process which is fully compliant with all regulatory definitions contained in the current European ATMP Regulation (EC) No. 1394/2007.

We also undertake all necessary steps to obtain the manufacturing license for the process and the product.