Abstract:
Cell and Gene Therapy (CGT) Products are exciting novel medicines belonging to the Advanced Therapy Medicinal Products (ATMPs). CGT products are characterized during validation studies in terms of critical quality attributes (CQAs) such as identity, purity and potency. Bioassays, in particular potency assays, are often at the center of many challenges throughout bioassay development and validation [1]. Potency assays are important tools in the potency assessment of CGT products not only in terms of product characterization but also for clinical efficacy. This poster presentation will demonstrate a methodological example of establishing and selecting CAR-T drug products for assay optimization and validation purposes applying bioequivalence testing.
Authors:
Roland J.W. Meesters, PhD, Scientist II, Cell and Gene Therapy Development Services
Ravi Vyzasatya, PhD, Director, Head of Cell and Gene Therapy Development Services