GMP Cell Therapeutics

Waisman cell culture specialists have a broad range of experience that enables us to optimize the culture parameters unique to each product cell line. Working in close contact with each client, we develop a culture process and timeline that meets program needs and cGMP/ICH cell banking requirements. The Waisman facility houses four ISO Class 7 Cell Processing Suites specifically designed for the cultivation of mammalian cells for use in 1) cell therapy applications including autologous cell processing, and 2) production of Master and Working Cell Banks for biotherapeutics production and ex-vivo gene therapies.

Cell Bank Specifics 

  • In-house QC testing for cell line characterization
  • Custom Cell Bank size, typically 100 – 500 vials
  • Control Rate Freezer for automated cryopreservation
  • Controlled/documented liquid nitrogen gas phase storage freezers 

Waisman Products and Processes

  • GMP human embryonic stem cell banks - visit our hES cell page
  • GMP induced pluripotent stem cell banks - visit our iPS cell page
  • Serum-free suspension and adherent HEK293 Master Cell Bank
  • Established processes for Mesenchymal Stromal Cells (MSCs), adipose derived stem cells, and differentiated cells (e.g. human neural progenitor cells, natural killer cells)
  • Custom tissue processing for allogeneic gene therapies

GMP Cell Banking / Cell Therapeutic Highlights

  • Suspension / adherent cell bank capabilities
  • Master / working bank options
  • Large scale bioreactor / multitray production
  • Vial / cryobag formats
  • Control Rate Freezer cryopreservation