Biologics of all kinds present development challenges in measuring product quality and consistency. This is just one area in which analytical laboratories provide a vital foundation to biopharmaceutical process and product development. Quality specialists help process engineers troubleshoot when things go wrong; formulators find ways to prioritize patients’ needs in drug-product design; validation and comparability specialists help ensure process and product consistency; and innovators find ways to apply new knowledge to process control.
This year's nominees in the Readers' Choice analytical category represent advances from across the bioprocess spectrum. Chilmonczyk and Fedorov show how a dynamic sampling platform addresses the clear industry need for an integrated PAT system for bioreactor monitoring. Mire-Sluis et al. report about presentations and discussions from the January 2019 CASSS CMC Strategy Forum, the agenda for which featured the definition, identification, control, and management of patient-focused attributes throughout the life cycle of biological products. Pathange, Shimoni, and Srinivasan chronicle their team's development of corrective and preventive actions when out-of-specification results arose during a perfusion culture process. And Shahrokh et al. address technical, practical, and regulatory facets of drug-product process validation and comparability.
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