Scil Proteins Production provides Contract Development and Contract Manufacturing services for cGMP and non-GMP projects with microbial expression hosts.

Contract Development Services:

  • Cell line design
  • Fermentation development (batch/fed-batch)
  • Refolding development
  • Downstream process (DSP) development
  • Development of analytical methods
  • PEGylation development

Contract Manufacturing Services non-GMP:

  • Feasibility studies
  • Production of protein material for preclinical studies and diagnostics
  • Production of proteins material for regulatory toxicology studies

Contract Manufacturing Services cGMP:

  • Tech transfer and scale-up
  • Production of clinical trial protein API (Phase I – III)
  • Production of protein API for market supply
  • Process validation
  • Analytical method validation
  • API release

Further Services:

  • Regulatory support and dossier generation
  • Project management
  • Stability studies according to ICH guidelines
  • Reference standard generation and characterization
  • Quality management for both non-GMP and cGMP services