A collaborative breakthrough in vaccine LBA validation standards
A recent White Paper entitled ‘Harmonization of Vaccine Ligand Binding Assays Validation’, developed through extensive collaboration between vaccine manufacturers, regulators and experts, addresses the critical need for harmonized guidelines in vaccine immunogenicity assay validation. This effort stems from a recognized regulatory gap impacting vaccine development, licensing and clinical evaluation.
Published in the journal Bioanalysis, the paper introduces Part 1 of a comprehensive series, focusing on vaccine LBA validation. The initiative, led by the Workshops on Recent Issues in Bioanalysis (WRIB) with input from 16 leading organizations, explores the unique challenges of measuring diverse and dynamic immune responses.
“Since 2017, participation in the WRIB working groups by vaccine assay validation experts and regulators has rapidly increased due to its unique format where industry leaders and regulators can meet and exchange ideas on topics of interest to both groups. In early 2021, vaccine manufacturers approached WRIB for sponsoring/supporting the authorship and publication of an overarching vaccine assay validation document based on the 2017–2020 discussions and consensus starting from immunogenicity assays first and followed by future papers on molecular and cell-based assay validation,” the authors explained.
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The WRIB publications agenda is currently drafting Part 2 (Vaccine LBA Development) and Part 3 (Vaccine LBA Monitoring & Transfer), which are expected to be published soon. Future publications will also extend guidance to molecular and cell-based assays, including ELISpot and PCR technologies. The initiative aims to bridge science and regulation to create standardized practices, ensuring consistent assay performance and advancing global vaccine innovation.
For more information, visit https://www.tandfonline.com/doi/full/10.1080/17576180.2024.2411925.
