Cell Bank Manufacturing
Create, characterize, and release.
Integrated cell bank manufacturing and characterization/release services are designed to certify safety and ensure cell line longevity over the life of your biopharmaceutical.
Cell Bank Manufacturing Overview:
GMP Master, Working, or End of Production Cell Bank Capabilities
Integrated Characterization and Release from incoming seed stock QA to COA
Experience with 50 plus cell lines; human and non-human
Sequencing to characterize insert
Surplus built into expansion plan – No loss of vials from testing
Standard Batch Records for efficient regulatory review
Support – Multiple shifts and Dedicated PM
Storage solutions available
Our Platform Approach to Cell Bank Manufacturing and Release
Understand and clarify process requirements, define Bill of Materials (BOM), and project timeline enabling us to create a tailored program.
Includes processing method and criteria, materials, table of participants, relevant SOP’s including media prep, expansion plan/vial fill, processing notes, equipment used, flask volumes, cell counts, and subculture seeding calculations.
Stringent raw materials release testing and incoming seed stock contamination screening includes: Sterility, mycoplasma, in-vivo, in-vitro adventitious virus, bovine/porcine 9 CFR, viral qPCR panels, TEM, F-PBRT for retroviruses, species identity, and genetic stability.
Verification run(s), capacity to manufacture 10-1,200 vials in HEPA-filtered suites with Class 5 laminar flow hoods.
In-Process Testing and Characterization
Recovery viability, cell count, cell growth, visual validation of morphology utilizing TEM, sterility, mycoplasma, virus screens, and tumorigenicity. Learn more about our Cell Line Characterization capabilities.
Sterility, B/F Testing, Mycoplasma Points to Consider, Post Bank Growth, fully executed batch record and test reports returned to customer for review prior to COA.
Working Cell Bank Creation
Take vials and begin the transition to create WCB’s per client specifications.