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Production of Recombinant Proteins

Richter-Helm BioTec

  • Development of production strains (E. coli, Pichia)
  • Optimisation of expression in different systems
  • Establishment of MCB/WCB
  • Development of fermentation (1 to 1,500 litres) and down stream processes
  • Development of analytical methods including bioassay development
  • Validation of analytical methods
  • GMP manufacturing for clinical phase I to III
  • Commercial GMP manufacturing
  • Process validation
  • In-house QC testing and release
  • Stability studies according to ICH

 

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