Working Cell Banks (WCBs) are a critical starting material for biologics manufacturing, yet the process by which WCBs are produced is often less characterized than the rest of the manufacturing process. The objectives of this project were to further characterize a typical WCB production process using a mammalian monoclonal antibody (mAb) cell line and identify areas of consideration during WCB process development and technology transfer/commercialization to ensure long term robustness and reliability.<br/>Case studies demonstrating enhanced WCB process understanding and characterization will be discussed, specifically: temperature sensitivity of cells during expansion stages, impact of cryoprotectant contact time during the pre-freeze stage, optimizing growth for yield enhancement, and new technology introduction including an automated cell counter to replace manual cell counting. Together, consideration of these factors during initial WCB process development will help ensure that more robust and reliable WCBs are in place for subsequent technology transfer/commercialization and mitigate potential WCB supply risks for biologics manufacturing.<br/>

Considerations during working cell bank manufacturing for long term robustness and reliability

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.