Flagship Project 3: Integrated PAT

Integrated process analytic technologies (PAT) for cell proliferation and recovery, including in-line and intermittent monitoring to promote efficacy and safety attributes for timely cell product release

Why?

Approaches to monitor and test the CQA – for example identity (phenotype), potency, efficacy, and purity of cells in real-time remains slow and cumbersome. Advancing this requires the development of new chemical, physical, microbiological, mathematical, and risk analysis tools collectively known as integrated process analytics technologies (PAT) so that the very cells that are expanded in vitro and intended to deliver to the patient can be analyzed prior to packaging and delivery.

FP3 develops and demonstrates process analytics technologies (PAT) and feedback control systems to monitor and modulate the appropriate release, recovery, and quantification of proliferating, adherent and suspended cells.