Validation aspects in the commercialization of integrated continuous biomanufacturing
October 6-10, 2019
Sanofi has been operating continuous processes for production of recombinant proteins for over two decades. Development of continuous processing unit operations has ever increasing attention across the biotechnology industry, including end-to-end continuous processing. The development of robust continuous processing steps enables integration of continuous unit operations. Recently, as part of second generation programs, integrated continuous biomanufacturing are being implemented for GMP manufacturing. This presentation will discuss aspects of equipment qualification and process validation that robust process development can facilitate.
Canghai Lu, "Validation aspects in the commercialization of integrated continuous biomanufacturing" 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/22