Harmonization of Vaccine Ligand Binding Assays Validation
Francis Dessy1, Ivo Sonderegger2, Leslie Wagner3
1GlaxoSmithKline, Rixensart, Belgium.
Bioanalysis
|November 14, 2024
Summary
Global efforts are underway to harmonize clinical vaccine assay validation, addressing a critical need for clear regulatory guidance in immunogenicity assays. This collaborative initiative aims to establish standardized validation practices for the vaccine industry.
Area of Science:
- Bioanalysis
- Vaccinology
- Regulatory Science
Background:
- Lack of clear regulatory guidance for vaccine immunoassay validation identified in the 2020 White Paper in Bioanalysis.
- The Workshop on Recent Issues in Bioanalysis (WRIB) yearly publishes recommendations on vaccine assay validation.
- Increased participation from vaccine assay validation experts and regulators in WRIB working groups since 2017.
Purpose of the Study:
- To address the urgent need for harmonized clinical assay validation in the vaccine industry.
- To develop an overarching document for vaccine assay validation based on WRIB discussions.
- To provide clear validation guidance for clinical vaccine immunogenicity assays.
Main Methods:
- Formation of a vaccine immunogenicity assay validation working group with 16 companies.
- Leveraging industry and WRIB vaccine networks for collaborative document development.
- Focus on developing consensus-based recommendations for assay validation.
Main Results:
- Initiation of work on Vaccine LBA Validation (Part 1) in April 2021.
- Ongoing drafting of Vaccine LBA Development (Part 2) and Vaccine LBA Monitoring & Transfer (Part 3).
- Future plans include recommendations for Vaccine Cell-Based Assays and Molecular Assays validation.
Conclusions:
- This collaborative effort aims to close the regulatory gap in vaccine assay validation.
- Standardized validation guidance is crucial for the vaccine industry.
- Future publications will extend recommendations to cell-based and molecular assays.
