Case Studies: Evaluating Checkpoint Receptor Bioassays: Fit-For-Purpose Assays Intended for Potency Testing of Therapeutic Candidates in QC Lot Release

Case Studies: Evaluating Checkpoint Receptor Bioassays: Fit-For-Purpose Assays Intended for Potency Testing of Therapeutic Candidates in QC Lot Release
Version:
21219

Year:
2021

Ready-to-Use qualified PathHunter® checkpoint bioassays are fit-forpurpose for potency testing for implementation in downstream development phases and Lot release of the biologic drugs at sponsors’ testing sites or their partner Contract Research Organizations (CRO)/Contract Development and Manufacturing Organization (CDMO). These bioassays are developed and optimized following systematic qualification studies to meet regulatory expectations. During these qualification studies, we evaluate the key attributes desired in a functional bioassay as defined by The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use and United States Pharmacopeia (USP) guidelines. These include accuracy, precision, linearity, range, specificity, robustness, and stability-indicating properties. These attributes are deemed critical in a bioassay when measuring drug potency and stability during drug manufacturing and release under quality control (QC) conditions. Therefore, qualification studies are key in demonstrating that the assay performance is robust and sensitive to measure manufacturing consistency, and measurements can be correlated with clinical outcomes of the drug candidate. Here, we present case studies on two PathHunter bioassays—the PD-1 Signaling Bioassay and the SIRPα Signaling Bioassay.