Services

cGMP Master Cell Banking

Master Cell Banking Services

Wheeler Bio provides cGMP Master Cell Bank (MCB) generation and characterization services to support monoclonal antibody and recombinant protein programs advancing to clinical manufacturing. Our cGMP cell banking services establish well-characterized production cell banks supporting reliable biologics manufacturing and clinical drug substance supply.


Good Manufacturing Practices compliant (cGMP) MCBs are generated with full chain-of-identity and chain-of-custody documentation from cell line development through GMP manufacturing. The Master Cell Bank serves as the primary source material from which Working Cell Banks are derived for cGMP production campaigns.


Characterization includes sterility, mycoplasma, identity, viability, and adventitious agent testing performed by qualified testing partners.


Early establishment of a well-characterized MCB supports rapid transition into process development and clinical manufacturing, helping reduce CMC timelines and mitigate risk for IND-stage programs.


Whether delivered as a standalone service or through Wheeler Bio’s ModularCMC® program, clients can seamlessly progress from cell line development to Master Cell Bank generation and cGMP drug substance manufacturing.


Learn more about Wheeler Bio’s master cell banking services.

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Master and Working Cell Bank Generation

ModularCMC Work Package 4


Wheeler Bio performs master cell banking as a stand-alone service, or as Work Package 4 in our ModularCMC offerings. Establishing a master cell bank (MCB) ensures a traceable and consistent production lineage for your cell line, forming the foundation for drug development and serving as the source from which Working Cell Banks (WCBs) are derived for cGMP production campaigns. To support this critical CMC milestone, Wheeler’s cell banking suite leverages automation, single-use technologies, and controlled cGMP procedures to protect cell bank integrity and ensure reproducibility. Cell banking operations are supported by regulatory-compliant monitoring of incubator and freezer conditions through the OSI PI Historian, providing continuous environmental oversight. Wheeler Bio also provides WCB generation and testing services, with bank sizes to support clients through commercial manufacturing.

Working and Master Cell Bank QC Testing

Wheeler Bio provides comprehensive quality control testing for Master Cell Banks (MCBs) to support regulatory-ready biologics development programs. Characterization and release testing are performed in and managed by Wheeler Bio’s in-house Quality Control laboratory, enabling efficient sample handling and close coordination between manufacturing and QC operations.

Testing programs align with ICH Q5D guidance for the characterization and qualification of cell substrates used in biological product manufacturing, supporting IND and BLA submissions. Characterization includes core assays for sterility, mycoplasma, identity, and endotoxin, with additional specialized testing performed through qualified external partners when required.

By integrating cell banking and QC testing within a single facility, Wheeler Bio ensures full chain-of-custody and efficient turnaround of critical characterization assays, helping clients establish well-characterized production cell banks suitable for clinical manufacturing.

Interested in partnering with Wheeler for master cell banking or working cell banking?