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Cell & gene therapeutics


Process development

  • Consulting
  • Selection of raw material
  • Transduction optimisation
  • Optimization of culture conditions
  • Assay development & qualification
  • Process adaptation & validation
  • Preparation of authority communication


Preclinic
  • Consulting
  • Production of preclinical material
  • Development of functional in vitro assays
  • Preclinical in vitro testing (according to GLP standard)


Early clinical development (phase I/II)
  • Consulting
  • Application for manufacturing license
  • Cell banking
  • Production of clinical grade product
  • QC analytics of product
  • Molecular patient monitoring


Late clinical development (phase II/III)
  • Production of clinical grade product
  • Cell banking
  • QC analytics of product
  • Molecular patient monitoring