GMP hES Cells

Waisman Biomanufacturing maintains Master Cell Banks of human embryonic stem (hES) cells (WiCell collaboration and NIH funding) produced under cGMP conditions for differentiating and use in human clinical trials as well as in research applications that are anticipated to lead to clinical development.

Human Embryonic Stem (hES) Cells

Waisman Biomanufacturing has established multiple hESC Master Cell Banks (MCB) through collaboration with WiCell or through NIH funding. Banks include:

  • H1 (WA01) - NHLBI PACT funding
  • H9 (WA09) - WiCell Collaboration
  • H14 (WA14) - NIH Center for Regenerative Medicine funding

Waisman Biomanufacturing will utilize hESCs from the MCB to create a second tier Working Cell Bank (WCB) that will be used specifically for each project.

Matched Research Banks

H9 and H14 have matched research banks derived from the GMP Master Cell Banks under identical culture conditions. These banks can be obtained through WiCell and evaluated for differentiation prior to investing in cGMP production.

hES Master Cell Bank Testing

  • Identity by microscopic morphology
  • Identity by STR
  • Flow cytometry for ESC marker expression
  • Viable Cell Count
  • Karyotype
  • Sterility
  • Mycoplasma
  • Adventitious Agent Testing

Contact us for more information on accessing these cell banks. Or, find out how we can help translate your differentiation process into a GMP compliant process suitable for clinical trial evaluation by visiting our GMP Cell Therapeutics page.