GMP-compliant Production of Clinical-grade API

Fraunhofer IME has a 600 m2 cleanroom facility as part of the institute site in Aachen.

Two independent multi-purpose lines for the production of recombinant biopharmaceutical proteins are installed in the facility, each consisting of a 15-100-350 L fermentation train 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-virus and post-virus inactivation in the downstream processing and can thus be used for mammalian cell culture processes as well. The second line is reserved for microbial processes.

RO-water, clean steam and WFI generators are located in the basement and supply the clean room areas. A central CIP station, also located in the basement, distributes CIP solutions to all rooms in which CIP-processes are to be carried out. Liquid waste streams contaminated with GMOs can be inactivated on-site in a thermal inactivation tank, whereas a walk-in autoclave can be used to decontaminate solids and equipment parts.

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.