CAP®: a completely documented human cell line ready for GMP production

  • CAP Cell Line of non-tumor human origin
  • Complete documentation of cell line development and full certification of materials on file at CEVEC
  • GMP-manufactured Master Cell Bank tested according to ICH Guidelines and WHO Recommendations for cell substrates
  • Biologics Master File for CAP Technology (BB-MF) submitted to U.S. FDA and referenceable for CAP Technology Licensees, simplifying regulatory approval process for a CAPderived product
  • Positive review of the technology from regulatory authorities