01.22.21 -- How To Create A Connected mAb Perfusion Process

Biomanufacturing is under increased pressure to adapt to market demands, such as reducing costs and bringing life-saving therapies to the people who need them faster. This article contains recommendations for the execution of a closed and connected mAb process from design considerations to scale-up, including the small-scale modeling that directed a process at manufacturing scale.

Closed connected processing poses new challenges with respect to process development, planning, and execution. This white paper reviews the benefits and challenges with closed processing and connected processing. By giving examples for the implementation of closed, connected processing in large-scale manufacturing, you will be able to explore and assess options that work for your objectives.

Within biopharmaceutical production there is a shift from manually monitoring processes to real-time control and automated intervention. The goal is to develop algorithms and AI solutions that are able predict outcomes and create autonomous systems. This paper exemplifies how to use available and reliable sensors for in-process control of several different upstream and downstream process parameters.

As process intensification is adopted into large-scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. Perfusion continues to be one such operating mode that lends itself to adding benefit at the manufacturing scale while adding complexity to the small-scale approach.