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 cell therapy suites that are specifically designed for the cultivation of mammalian cells for use in cell therapy applications that include production of master and working cell banks for biotherapeutics production and ex-vivo gene therapies.  All cell therapeutic production campaigns are performed in one of our four ISO Class 7 Cell Processing Suites (Facility/Cell Processing Suites).

Cell Bank Specifics 

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

Waisman Products

• First cGMP non-feeder human embryonic stem cell bank
• Human neural progenitor cell bank
• Serum-free HEK cell bank
• Tissue for allogenic gene therapies
• Genetically modified cell lines for patient transplantation
• Pancreatic islet cell harvesting for transplantation

• WHY WAISMAN Clinical Production
• GMP Plasmid DNA
• GMP Protein Production
• GMP Cell Therapeutics
• GMP Viral Vectors / Vaccines
• Aseptic Fill / Finish