Head of Production and R&D
At our development and production plant in the Luckenwalde Biotechnology Park, we have years established a globally unique production process for the production of our BCG strain (Bacillus Calmette-Guérin) for the treatment of non-muscle invasive bladder cancer (NMIBC). This step provides an important basis for a comprehensive expansion of the company.
The Luckenwalde production site is a state-of-the-art facility and was developed according to the “Quality-by-Design” principle. The production rooms were built especially for the production of BCG and are subject to the requirements of the cleanroom classification according to cGMP. After three years of process development and the establishment of a quality management system, PharmaCept GmbH received the GMP certificate and the manufacturing permit for the manufacture of BCG at the beginning of 2019.
The project on which this report is based was funded by the Brandenburg Ministry of Economics and European Affairs. The author is responsible for the content of this publication.