Sensors for biomanufacturing process development: facilitating the shift from batch to continuous manufacturing

[摘要] The biopharmaceutical industry has traditionally utilized batch manufacturing strategies for production, but continuous manufacturing has been explored as an alternative production method in recent years because of the potential financial and quality benefits. The complex nature of this manufacturing method requires robust online process analytical technology (PAT) that can effectively characterize continuous processes at the development scale (0.1–100 mL for process scouting devices (PSDs) and 100 mL–10 L for bench-scale development) as well as sensors that can monitor and control them at the commercial scale (hundreds to thousands of liters). Both established and new bioprocessing sensor technologies for characterizing and monitoring batch and continuous bioprocesses are explored in this review and are evaluated for their potential use in continuous bioprocess development and in commercial-scale production. Not all of these sensors can be integrated with control systems for end-to-end continuous bioprocesses at the commercial scale, but they can currently be used to gain a better understanding of new continuous processes at the development scale in order to make the scale-up process more data-driven, improving process understanding.

[学科分类] 工业化学