October 6-10, 2019
Continuous Bioprocessing is perceived to deliver constant product quality and to achieve higher time space yields. This is not new. Other market segments run well established continuous processes successfully since decades. What do we need to do? Just establishing continuous single unit operations (e.g. SMB chromatography) will not suffice. We need to have an integrated look at the entire process chain and stringently use the following control strategies :
- Capture process variability of the preceding unit operation using advanced PAT tools. Just measuring CPPs will not suffice: We need RMAs and intermediate CQAs to be transparent across the process chain.
- Include above variability in the control strategy of the individual unit operations, carry out sound process characterization using data science tools.
- Have clear specifications for intermediate acceptance criteria (IACs), such as distributions of expected outputs of intermediate CQAs
- Apply advanced process control strategies, such as multiple input multiple output controllers to robustly link process chain elements.
- Be aware that additional variability may occur along the life cycle. Hence, establish holistic manufacturing control strategies fulfilling Established Conditions (ECs) along ICH Q12 rationales.
Please click Additional Files below to see the full abstract.
Christoph Herwig, "Control strategies for integrated continuous bioprocessing" 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/67