5/21/2023 0 Comments Process monitoring system4 A holistic understanding of the development process is a key prerequisite for designing a QbD roadmap where appropriate analytical technologies and cyber-physical systems must be deployed for real time monitoring of critical product quality attributes (CQAs), critical process parameters (CPPs) at critical control points (CCPs). 2,3 As defined by the International Conference of Harmonization, QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. 1 Robust platforms for ensuring consistent product quality through Quality by Design (QbD) approaches are becoming a necessity as biologic drugs gained popularity over the last decade. Real time monitoring of biopharmaceutical process development has evolved significantly in recent years with the advancement of analytical technologies, cyber-physical systems and advanced-data interrogation tools.
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