apceth Received Extended Manufacturer's Licence for Somatic Cell Therapeutics At The Ottobrunn Site
Adult stem cell research at the highest level will be possible at the new apceth site in Ottobrunn near Munich, Germany: in August 2011, the Munich biotech company was granted a manufacturer's licence pursuant to Section 13, German Medicines Act, for the production of somatic cell therapeutics at the new research and production facilities. Together with the already operational site at Munich Großhadern, apceth now has two highly efficient and GMP-compliant building complexes that have cleared the high certification hurdle. "Thanks to the new capacity, we are now in the position to push ahead more quickly with our own development projects and to offer our know-how and our premises to co-operation partners", explained apceth CEO Dr Christine Günther. CSO Prof. Ralf Huss added: "This has enabled us to further close the gap between research and clinical application".
1,800 square metres for research
The apceth site in Ottobrunn covers a total of 1,800 square metres, of which 457 m2 are cleanroom space. Thus, together with the GMP premises in Großhadern, apceth now has a total of 600 m2 cleanroom space at its disposal. This is divided among five separate cleanroom suites (ISO8, ISO7, ISO5). The units are equipped with storage tanks for liquid nitrogen for storing the cell preparations and a total of six incubators for cell expansion. These are monitored around the clock by the company's own Quality Control staff.
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