Process Development & Manufacturing

Our Process Development and Manufacturing teams develop ingenious large scale, closed system and cGMP compliant manufacturing processes and manufactures innovative cell and gene therapies.

Process Development

  • Scale up/scale out/technology development
  • Raw materials/vendors sourcing, qualification
  • In process/release test development
  • Process and reagent qualification

Clinical Materials Production

  • Cell Selection (Phenotype, cytokine expression, size)
  • Cell expansion (flasks, static bags, bioreactor)
  • Genetic modification (Viral Tdx, CRISPR, etc.)
  • Cell/Device Preparation (Skin grafts, iPSC-derived grafts)
  • Viral Vector Production (AAV, Lentivirus)