Article | August 27, 2021

Enabling Advanced Process Control And Continuous Verification For Biopharmaceutical Manufacturing

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Quality by Design (QbD) is risk-based amalgam of advanced process controls (APC) that comprise of integrated and aggregated real-time and near real-time (at-line) process analytical technologies (PAT) that enable enhanced process trajectories and intermediate material quality attribute(s) determinations (IMQA).  A process control space is derived when this collection of real-time analytics is combined with post manufacture determination of drug substance (DS) or drug product (DP) critical quality attributes (CQAs) or the quality target product profile (QTPP).  Furthermore, cultivation of the broader design space via process stretching and failure mode evaluations during process development and scale-up campaigns.  Continuous process verification is an additional QbD beneficial construct derived from a robust APC strategic and enabled design.

The lowest level of quality is dependent upon procedural batch executions and post DS or DP manufacture quality target profile determination where limited or negligible PATs are implemented and utilized within the GMP landscape.

This article reviews how integrating aggregated photometric sensors and at-line analyzers across upstream and downstream biomanufacturing unit operations forms a more robust strategic approach as they are more cost effective, efficient to implement, and sustain to enable advanced process control and continuous process verification, to thereby cultivate a desired QbD design as part of an effective quality program.

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