Vaccine Ligand Binding Assay Life Cycle Management, Assay Maintenance, Monitoring and Transfer.

This white paper focuses on maintenance, monitoring and transfer of Ligand Binding Assays (LBAs) supporting vaccine immunogenicity studies and is part 3 of a series to harmonize method validation and bioanalysis. The objective of this series was identified during the drafting of the 2020 White Paper in Bioanalysis. The Workshop on Recent Issues in Bioanalysis (WRIB) produces the White Paper in Bioanalysis yearly, which is one of the high-profile articles published in the journal, providing detailed discussions and recommendations on Bioanalytical Method Development and Validation. Since 2017, participation by vaccine assay validation experts and regulators in the WRIB working groups has rapidly increased due to its unique format where industry leaders and regulators can meet and exchange ideas on topics of mutual interest. In early 2021, vaccine manufacturers approached WRIB to sponsor and support the authorship and publication of an overarching vaccine assay validation document based on the 2017-2020 discussions and consensus, starting with LBA, then followed by future papers on Molecular Diagnostics (MDx including both PCR and NGS), Biofunctional Assays (BFA) and Cell-Mediated Immunity (CMI) assays validation. Using the industry and WRIB vaccine network, a vaccine immunogenicity assay validation expert working group was assembled representing 16 global companies. The work on the first 3 white papers officially began in April 2021 focusing on vaccine immunogenicity ligand binding assays (Part 1 LBA Validation, Part 2 Assay Development, Part 3 Assay Lifecycle Management, Assay Maintenance, Monitoring and Transfer). In this publication (Part 3), the activities that are required to ensure consistency of assay performance following validation are discussed. In contrast to bioanalytical methods evaluating chemical and biological drugs (ICH-M10), there are no clear guidelines for methods supporting vaccine immunogenicity studies. Hence, the authors of this White Paper hope that this common effort will help close this regulatory gap. These harmonization white papers will collectively be pivotal for whole vaccine development process.