About Us
Apceth GmbH & Co. KG is a bio-pharmaceutical company dedicated to the development of innovative cell therapy products. Apceth has established a unique GMP-certified production system to expand human adult stem cells. Apceth uses this platform technology to develop and produce advanced somatic cell and gene therapeutics for the treatment of non-malignant medical conditions and cancer. In the development and production process Apceth relies on advanced technologies, outstanding know-how and a rigorous quality control system.
Apceth was founded in November 2007 as a bio-therapeutic startup funded by a private investor with long-lasting experience in the pharmaceutical business. Since the foundation Apceth pursues a vibrant business and development strategy. Being located within Germany´s largest biotech region in Munich-Martinsried Apceth benefits significantly from direct proximity to the lively centers of clinical and scientific excellence.
The company opened its doors in 2008 after the construction of the R&D laboratories and core Cleanroom and quality control GMP-facilities had been completed. This unique GMP/S2 Cleanroom area allows production of Apceth cell therapy products at the highest technical standard. As of 2010 Apceth is further extending its GMP facilities to four additional Cleanroom suites and adjoining quality control units. The large manufacturing capacity enables Apceth to offer contract GMP-manufacturing services of cell products to customers.
In 2010 Apceth successfully passed the GMP-inspection by the state authorities and obtained the Manufacturing License according to §13 of the German drug law (AMG) for production of somatic cell therapeutics as one of the very first companies in Germany. The Manufacturing License was issued by the Bavarian Government and approved by the Paul-Ehrlich-Institute (PEI). It enables the production of Advanced Therapy Medicinal Products (ATMP) based on somatic cells for Apceth’s own needs and initiation of the first clinical trial with Apceth somatic cell therapeutics, as well as contract manufacturing of somatic cell products.
Download: Manufacturing License
Download: Certificate of GMP Compliance
Download: License for Procurement and Testing of Tissue
The unique state-of-the-art facilities enable Apceth to shorten the time required to translate innovative ideas and basic research into novel cell therapies for the benefit of patients and clinicians.