Bioanalytics – Biomolecular
2019 PharmSci 360
An integral part of immunogenicity assessment of biologics is the development of validated ADA assays, including screening, confirmatory, titering and when needed, neutralizing antibody assays. This is known as the SCT-NAb me dance, which involves heavy participation from the immunogenicity SME (“immunerdy”) community from both industry and regulators. My presentation will provide a “dance floor” perspective of an FDA Immunogenicity Assessor from CDER’s Office of Biotechnology Products regarding the AAPS efforts to create a harmonized ADA assay validation template to facilitate both industry activities and regulatory review processes.