GMP MSCs

Waisman Biomanufacturing with sponsorship from NIH/NHLBI maintains banks of bone-marrow derived Mesenchymal Stromal Cells (BM-MSCs), also called Mesenchymal Stem Cells, produced under cGMP conditions for expansion and use in human clinical trials as well as in research applications that are anticipated to lead to clinical development. Initial bone marrow aspirates were collected with full informed consent and 21 CFR 1271 Donor Eligibility Testing. The aspirates were processed under cGMPs and banked at an early passage for subsequent expansion for clinical Drug Product. Options also exist for custom donor acquisition through a collaborator's IRB and Master Cell Bank production.

 

 

Platform Manufacturing Processes

Waisman Biomanufacturing has established cell culture processes and quality control methods for expanding MSCs for early stage clinical trials.

  • Expansion to 2-4x109 cells per lot
  • Final product in vials or bags
  • Custom formulations including cryopreservation

 

MSC Master Cell Bank Testing

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

Custom Quality Control Methods

Additionally, Waisman has experience developing and qualifying surrogate potency assays including:

  • Functional immunosuppression assays
  • Multiplexed ELISA for cytokine profile
  • Custom flow cytometry assays for MSCs from alternate sources

Waisman Biomanufacturing will utilize MSCs from the MCB to expand as Final Drug Product for human clinical trials.

Contact us for more information on accessing these cell banks.