Products & Services

Contract cGMP Development and Manufacturing Services

FCDI's cGMP development and manufacturing process

Key Aspects

  • Donor blood sample: 21CFR compliant
  • Haplotype matching and prioritization
  • Differentiation representative of all 3 germ layers
  • Custom cGMP iPSC manufacture and banking
  • DMF and regulatory support documents available
  • License to exclusive episomal platform technology included
  • One cGMP MCB in phase I clinical trials
  • CDMO services available for differentiation

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