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Process Technology

Based on the definition of the most appropriate expression system, a fermentation procedure will be designed. The conditions needed for a robust process on an industrial scale will be defined. In case of Active Pharmaceutical Ingredient (API) a GMP complianced producation process on a 350 L scale will be sufficent for many needs.

In parallel, the developmental activities pertain to an effective and adequate purification process capable to remove process-related impurities of different nature, e.g. cell proteins, DNA, endotoxines, microbial load.  

The steps may include a technology transfer from laboratory with non-GMP equipment to the Fraunhofer IME GMP-facility. The production technology refers to the upstream - and downstream processing. Some typical steps are listed in the following:

  • Cell banking
  • Fermentation
  • Bioreactors: 16 folds parallel bioreactor, bioreactors from 1 to 30 L as well as two multi-purpose production lines with 100 and 350 L
  • Homogenization
  • Centrifugation
  • Virus inactivation
  • Chromatographic purification (e.g. AEX, CEX, IMAC, Protein A affinity chromatography, Gelfiltration)
  • Filtration (e.g. cross flow filtration, sterile filtration)