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The process analytical technology (PAT) and quality by design (QbD) guidelines promoted by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) support the idea that quality cannot be “tested into” a biologic product but must instead be part of its process design. Seamless integration of analytical data with bioprocess monitoring and control is crucial to understanding a process and overcoming manufacturing challenges that arise in the course of development.
By Célia Sanchez, Laure Pétillot, Fabrice Thomas, Charlotte Javalet In the context of Process Analytical Technologies (PAT) implementation in the biopharmaceutical industry, Quality by Design (QbD) is being developed and widely implemented and used. In upstream processes, one compound of great interest to monitor is glucose, and specifically, being able to control its concentration during the process.
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