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Continued process development for monoclonal antibody (mAb) for more efficient manufacturing schemes is required to meet ever increasing patient needs. Process development for most mAb manufacturing focuses on Chinese hamster ovary (CHO) cells, as this host is relatively mature and has a long history of producing products with demonstrated safety to patients, high process yields, and suitable product quality requirements for human use. MAb process development is divided into upstream and downstream processing. The focus of this presentation is the upstream portion, which starts with the thaw of a cell bank vial, proceeds to seed culture expansion, and then finally to production in large-scale bioreactors. Recent advances in upstream process development will be discussed, including cell line generation strategies, medium development, bioreactor parameter optimization, high throughput screening, process analytical technology tools, omics pathway analysis and process modeling, upstream control of quality attributes, platform development and implementation, and scale-up manufacturing. In the second half of the seminar, we will focus on three hot upstream topics in detail, e.g., upstream levers for control of drug substance quality attributes, process intensification for improvement of manufacturing productivity, facility throughput / cost reduction, and process development at pandemic speed for anti-SARS-CoV-2 neutralizing mAbs. Future perspectives will be summarized in the end.
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