GMP-compliant Production of Clinical-grade API

Fraunhofer IME has erected a 600 sqm cleanroom facility as a part of the new institute building in Aachen.

Two independent multi-purpose GMP production lines for the production of recombinant biopharmaceutical API are installed in the facility, each consisting of a 15-100-350 L fermentation trains and matching downstream processing equipment. Rooms for in-process-controls, media and buffer preparation, cleaning and storage of equipment round off the facility.

One line features separate class C rooms for pre and post virus inactivation in the downstream processing and can thus be used for mammalian cell culture processes. Line 2 is suitable for microbial processes.

RO-water, clean steam and WFI generators are located in the basement and distributed to the clean room areas. A central CIP stations, also located in the basement, distributes CIP solutions to all rooms in which CIP-processes are to be carried out. Large volumes of liquids contaminated with GMO can be inactivated in a thermal inactivation tank.

The facility has been inspected by the local authorities in 2008 and 2009 and a manufacturing authorization and GMP certificate have been issued.

The facility has also undergone two customer audits in 2009 and 2010 without critical observations or remarks.