Biopharmaceutical Development - Focus CMC

  • Definition of an individual process strategy (expression, fermentation, purification, modification- PEGylation or conjugation) to fit the desired Target Product Profile (TPP)
  • Regulatory support for CMC strategy - Special fields: biosimilars and biobetters
  • IP strategy for non-infringement of processes
  • Process development for GMP API manufacture. USP (fermentation) and DSP (protein purification)
  • Process characterisation in USP and DSP
    • Definition CQAs, CPPs, Design Space (ICH Guideline Q8)
    • Planning of representative studies with scale down models
    • Risk assessment
  • Process validation USP and DSP
  • Drug Product development
    • Galenic development – liquid protein formulations
    • Modification of the active ingredient molecule (PEGylation, toxin conjugation)
    • Final dosage forms, application devices (PFS, pen)
  • Process improvement and adjustment
  • Bioassay development

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