BI Fremont Inc and Pfizer are investing in intensified (continuous/integrated) processing to provide early stage clinical material radically cheaper and with little development, while keeping in mind a path to commercialization. We developed a process that is capable to making 1kg mAb of drug substance in in ≤15 days using 100 L bioreactor. Our processes is highly automated, reduces in process pools, it is fully disposable, and it is GMP capable. We have focused on solving challenging new technologies; an example is continuous viral inactivation. For this unit operation, we addressed dispersion and characterized the minimum residence time, tmin, for a novel, scalable, and sturdy tubular reactor design that can serve as an incubation reactor [1,2]. We have set the foundation for a trace response method to be used as a way to verify that the process was properly set up. Finally, we also developed a viral clearance strategy for this unit operation. The entire continuous integrated process will be discussed in addition to the continuous virus inactivation.
1. Orozco, R.; Godfrey, S.; Coffman, J.; Amarikwa, L.; Parker, S.; Hernandez, L.; Wachuku, C.; Mai, B.; Song, B.; Hoskatti, S.; Asong, J.; Shamlou, P.; Bardliving, C.; Fiadeiro, M., Design, construction, and optimization of a novel, modular, and scalable incubation chamber for continuous viral inactivation. Biotechnology Progress 2017, 33, (4), 954-965.
2. Parker, S. A.; Amarikwa, L.; Vehar, K.; Orozco, R.; Godfrey, S.; Coffman, J.; Shamlou, P.; Bardliving, C. L., Design of a novel continuous flow reactor for low pH viral inactivation. Biotechnology and Bioengineering 2017.