Session IV: Bioassays for Vaccines and Antibody Therapies with Discussion

The pandemic of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has significantly impacted the lives of the global human population. Many biotech and pharmaceuticals companies are pursuing the development of effective therapeutic and preventive approaches including small molecule drugs and biologics (antibodies, vaccines, etc) at ‘break-neck’ speeds, with some having received emergency-use authorization in the U.S. as well as global marketing authorization approvals. This session will focus on examples of technical challenges encountered in developing appropriate potency assays as well as strategies for accelerated potency assay development for their therapeutic modalities. This session will also focus on a recent round-table discussion and FDA guidance on the development and use of potency assay for biologics targeting SARS-CoV2.