Biogen is taking a holistic approach to develop and implement an end to end advanced process control (APC) strategy for our late stage monoclonal antibody processes with a goal to improve process robustness, consistency and operation efficiency. This APC strategy is developed based on comprehensive product and process understanding and consists of four major components, including prospective raw material control, dynamic feedback and feed forward process controls, “right time” release and predictive models.  Under this APC paradigm, raw material variability and the impact on process performance are well understood through extensive raw material lot screening and process characterization. Inline and at line measurements, feed-back and feed forward controls are used in production bioreactor and selected purification steps to improve process consistency and robustness.  Rapid analytical technologies including multi-attribute assay are deployed to support right time release at selected intermediate process steps instead of the final drug substance step. Finally, consistency and predictive models are developed as needed and feasible to support product quality assessment and batch release.  This presentation will describe how these components are integrated to deliver a more robust process control and efficient manufacturing over traditional process control; considerations on process validation under this APC paradigm; and learning from manufacturing implementation.

Advanced process control strategy for consistent product quality and improved manufacturing efficiency

253rd National Meeting (2017)

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