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 scalable, aseptic culture processes that meet program needs and CGMP regulations.

The Waisman facility maintains four ISO Class 7 Cell Processing Suites specifically designed for the cultivation of mammalian cells for use in 1) allogeneic and autologous cell therapy applications, and 2) production of Master and Working Cell Banks for biotherapeutics production and ex-vivo gene therapies. 

GMP Cell Therapeutic Capabilities

• Suspension / adherent cell capabilities
• Large scale bioreactor / multi-tray production (suspension bioreactors, Cell Factory/Cell Stack, Hyperstack configurations)
• Harvest and washing by continuous centrifugation technologies (e.g. kSep and LOVO)
• Vial / cryobag formats
• Full Quality Control support

Cell Bank Specifics

• Custom Cell Bank size, typically 200 – 500 vials
• Control Rate Freezers for automated cryopreservation
• Controlled/documented vapor phase liquid nitrogen storage
• In-house QC testing and qualified contract vendors for cell line characterization and adventitious agent testing

Waisman Products and Processes

• GMP human embryonic stem cell banks - visit our hES cell page
• Extensive experience with reprogramming, expansion, and differentiation of human induced pluripotent stem cells from multiple sources
• Established processes for Mesenchymal Stromal Cells, adipose derived stem cells
• Other adult cell therapy applications including custom and engineered tumor cell lines and other cell types
• Custom tissue processing for allogeneic gene therapies