The Impact of Novel PAT and Rapid Tests on Continuously Produced Protein
Process and product understanding is at the root of manufacturers’ efforts to produce safe and effective medicines. While Quality by Design has been a successful approach for maintaining product quality, its adoption is a byproduct of difficulties in measuring product quality in real time. Real-time measurement of product quality and safety has the capacity to dramatically reduce the burden of process development. The continuous manufacturing paradigm will also require the development of new tools that provide greater visibility into process performance, especially with regards to adventitious virus.
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