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GMP facility

All GMP production will take place in cooperation with the Fraunhofer Society.

To guarantee the quality and safety, a state of the art GMP facility has been established at Fraunhofer IME in Aachen, comprising almost 600 sqm floor space (plus storage area). It features two fermenter trains, one is especially laid out for the fermentation of mammalian cells. 

Thus all established production systems ranging from bacterial and eukaryotic microorganism to mammalian cells can be processed. The reactors are capable to conduct batch, fed batch and perfusion processes.

The following premises and equipment elements have been established:

  • cleanrooms  (class C, D and A in C) with material and personnel airlocks
  • 2 multipurpose production lines of 100 and 350 L fermentation volume
  • cleaned media  (purified water, water for injection)
  • other media (gases)
  • cleaning and sterilizing systems (CIP/SIP)
  • monitoring (particulate matter, microbial count, temperature, pressure)
  • pre- and post virus inactivation production area