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Cell Banking with CDMOs

July 14, 2021



Cell bank manufacturing and release services must prioritize the most stringent safety requirements and aim to optimize cell line longevity over the life of your biopharmaceutical.

An optimized cell bank manufacturing service should offer:

• The capacity for extensive cell bank production (GMP Master, Working, End of Production) QA to COA for integrated characterization and release purposes.

• The flexibility to work with as many human and non-human cell lines as possible to best suit your project.

• Sequencing optimization for insertion characterization and genetic modification purposes.

• Utilization of surplus material to prevent loss of vials or precious data through testing.

• Accurate and in-depth standard batch records.

• Constant support from a team of industry experts with the knowledge and experience to optimize your project’s unique process.

• Various storage solution options.

Ideally, you should be able to consult with your CDMO to create a custom program that fits your project’s specific needs. The custom program should optimize process requirements, BOM, and establish a full project timeline.

When developing your project’s batch records, your CDMO should have a specific processing methodology, selected criteria, measured materials, a full list of participants, standard operating procedures with media planning and expansion planning, processing notes, necessary equipment, flask volumes, cell numbers, as well as subculture seeding calculations.

Testing for safety and purity is essential. Your CDMO partner should conduct release tests for all of your project’s raw materials, as well as analyze seed stock for potential contamination. Screening processes should test for your stock’s sterility, mycoplasma, in-vivo/in-vitro adventitious virus, bovine/porcine 9 CFR, viral qPCR panels, TEM, F-PBRT for a retrovirus, species identity, as well as genetic stability.

For harvesting and cellular expansion, your CDMO should offer the most manufacturing capacity possible (a minimum of 1200 vials). After verifying your cells, vials should be stored safely in HEPA-filtered suites. Tests must also be conducted in-process and for characterization. Measuring for recovery viability, cell count and growth, visual morphology validation, and tumorigenicity.

Your CDMO’s expert team should work with you to optimize your process, determining which tests to conduct for your unique project, and at what stage these tests should be administered in development. They should enforce only the highest quality standards to ensure the best results for your project and infuse their team’s experience, expertise, and knowledge to make your work a true breakthrough and revolutionary cure for patients in need.

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