Cell therapies such as CAR-T and CAR-NK become more efficacious and cost effective through (1) automation and improvements in process control and (2) improved CAR design. Next generation protein sequencing (NGPS) allows discovery of (or understanding and engineering of) scFv and hinge regions from IgG for modulation of binding affinity, epitopic activity and FcγR activity – key insights for rational design. NGPS also allows for rapid assay development by finding and engineering good binders, identification of PTMs, development of enrichment tools for manufacturing/production, as well as development of validation tools for in vivo assessments.
Gene therapies require study by NGPS in order to identify PTMs associated with viral vectors (e.g. AAV) and to sequence, study, and engineer the viral capsid protein.