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:
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GMP Master, Working, or End of Production Cell Bank Capabilities
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Integrated Characterization and Release from incoming seed stock QA to COA
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Experience with 50 plus cell lines; human and non-human
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Sequencing to characterize insert
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Surplus built into expansion plan – No loss of vials from testing
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Standard Batch Records for efficient regulatory review
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Support – Multiple shifts and Dedicated PM
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Storage solutions available
Vial Capacity
Our Platform Approach to Cell Bank Manufacturing and Release
Consultation
Understand and clarify process requirements, define Bill of Materials (BOM), and project timeline enabling us to create a tailored program.
Consultation
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.
Consultation
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.
Consultation
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.
Release Testing/COA
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.