GMP iPS Cells

Waisman Biomanufacturing has established processes for banking human induced pluripotent stem (iPS) cells through collaboration with Cellular Dynamics International. Master Cell Banks can be 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. We have also established Quality Control methods for cell bank testing under cGMP/ICH regulations and guidances.

Typical iPS Master Cell Bank Testing

  • Identity by microscopic morphology
  • Identity by STR
  • Assays for pluripotent marker expression
  • Viable Cell Count
  • Karyotype
  • Sterility
  • Mycoplasma
  • Adventitious Agent Testing
  • Residual Reprogramming Vector

 

(Coming Soon!) Induced Pluripotent Stem (iPS) Cells

Waisman Biomanufacturing has partnered with Cellular Dynamics International to use GMP iPSC Master Cell Banks for future production of iPSC-derived cell therapeutics. Under this program, Waisman Biomanufacturing will use iPSCs from the MCB to create a second tier Working Cell Bank (WCB) that will be used specifically for each project.

Contact us for more information on accessing these cell banks.

Photo courtesy of James Thomson.