Implementation of an integrated continuous downstream process for a monoclonal antibody production
October 6-10, 2019
The biopharmaceutical market is driving the revolution from batch to continuous manufacturing (CM) for higher productivity and lower cost. In this work, a bench-scale fully integrated continuous downstream process for monoclonal antibody production was established and successfully scaled up to 200 L scale. The process includes a continuous proteinA step, a viral inactivation step, a batch-wise cation exchange and anion exchange step, a batch-wise viral-filtration step, and a single-pass UF/DF step. An inline protein quantity monitoring system was designed to control protein loading mass on cation exchange column. All the steps were connected through surge tanks and integrated by DeltaVTM automatic control system.
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Wei (Heidi) Gong, Ran Chen, Bin Yao, Xujun Chen, Biao Jiao, and Wei Wang, "Implementation of an integrated continuous downstream process for a monoclonal antibody production" in "Integrated Continuous Biomanufacturing IV", Veena Warikoo, Roche, USA Alois Jungbauer, BOKU, Austria Jon Coffman, Boehringer Ingelheim, USA Jason Walther, Sanofi, USA Eds, ECI Symposium Series, (2019). https://dc.engconfintl.org/biomanufact_iv/1