This project addresses key challenges faced by both manufacturers and regulators, with regards to both continuous product quality measurements and rapid adventitious agent detection methods. We are developing novel measurement techniques to provide protein quality analysis in real time. We will optimize these technologies for bioprocesses, and subsequently deploy them in an antibody production testbed to assess the impacts of using these technologies for process monitoring and control.
The insights derived from this project will allow regulators and manufacturers to understand the effects of new process analytical technologies (PAT) on product quality and viral safety assurance, and will reduce the uncertainty that will be faced by manufacturers adopting new PAT.
- FDA Center for Drug Evaluation & Research