Vaccine Ligand Binding Assay Development

This white paper (Part 2 of a series on vaccine immunogenicity assay validation) addresses the development of Ligand Binding Assays (LBAs) to support vaccine immunogenicity studies. Developed through a collaborative effort by a working group of experts from 16 global vaccine manufacturers, national regulatory authorities, and a nonprofit global-health foundation convened under the Workshop on Recent Issues in Bioanalysis (WRIB), this manuscript provides practical guidance to complement existing regulatory frameworks for bioanalytical method validation.Part 2 details the iterative process of LBA development, with emphasis on defining the Analytical Target Profile (ATP) as a foundational tool for guiding decision-making across the assay life cycle. Key topics include assay purpose and analyte specificity, regulatory expectations, the use of statistical Design of Experiments (DOE) to systematically optimize assay conditions, and the selection of appropriate reagents, controls, and sample matrices. The paper also addresses the unique challenges posed by the structural diversity of vaccine antigens and the need for representative reference materials.The manuscript further highlights the importance of ongoing performance assessment and the adaptability of assays as they transition from early exploratory phases to pivotal clinical studies. Collectively, the recommendations presented aim to supplement existing regulatory guidance with vaccine-specific considerations, ultimately supporting the development of safe and effective vaccines. This paper is complemented by Part 1 (LBA Validation) and Part 3 (Assay Lifecycle Management, including Maintenance, Monitoring, and Transfers).

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Publication Details

Journal
Bioanalysis
Published
2026-08-21
DOI
https://doi.org/10.1080/17576180.2026.2708544
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
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article

Vaccine Ligand Binding Assay Development

Alessandra Buoninfante, Núria Guimerà, Ivo Sonderegger, Luc Gagnon et al.
Bioanalysis
Biosimilars and Bioanalytical Methods
article

Vaccine Ligand Binding Assay Development

Alessandra Buoninfante, Núria Guimerà, Ivo Sonderegger, Luc Gagnon, João Tavares Neto, Katrina Nolan, Shannon Harris, Akiko Ishii‐Watabe, Bart Corsaro, C. B. Tan, Fabio Garofolo, Meenu Wadhwa, Sankeetha Nadarajah, Thorsten Verch, Ralf Jaeger, Shane Cloney-Clark, Lingyi Zheng, Dulcyane Neiva Mendes, Roy Helmy, Anastasia Aksyuk, Dewal Jani, Jean‐Claude Marshall, Leslie Wagner, Angelique Baclin, Karen Makar, Christian Mayer, Marie Bonhomme, Joyce Plested, Joseph Agnes, Louis Fries, Peter Giardina, Deidre Wilkins, Tina Green, James Huleatt, Sarah Janssen, Lisa Kierstead, Rocio Murphy, Chad Irwin, Jeroen Stoop, Arron Xu, Ingrid Scully, Francis Dessy, Mingzhu Zhu, Julie Joseph
article en

Abstract

This white paper (Part 2 of a series on vaccine immunogenicity assay validation) addresses the development of Ligand Binding Assays (LBAs) to support vaccine immunogenicity studies. Developed through a collaborative effort by a working group of experts from 16 global vaccine manufacturers, national regulatory authorities, and a nonprofit global-health foundation convened under the Workshop on Recent Issues in Bioanalysis (WRIB), this manuscript provides practical guidance to complement existing regulatory frameworks for bioanalytical method validation.Part 2 details the iterative process of LBA development, with emphasis on defining the Analytical Target Profile (ATP) as a foundational tool for guiding decision-making across the assay life cycle. Key topics include assay purpose and analyte specificity, regulatory expectations, the use of statistical Design of Experiments (DOE) to systematically optimize assay conditions, and the selection of appropriate reagents, controls, and sample matrices. The paper also addresses the unique challenges posed by the structural diversity of vaccine antigens and the need for representative reference materials.The manuscript further highlights the importance of ongoing performance assessment and the adaptability of assays as they transition from early exploratory phases to pivotal clinical studies. Collectively, the recommendations presented aim to supplement existing regulatory guidance with vaccine-specific considerations, ultimately supporting the development of safe and effective vaccines. This paper is complemented by Part 1 (LBA Validation) and Part 3 (Assay Lifecycle Management, including Maintenance, Monitoring, and Transfers).

Bioanalysis
Health Canada (CA), Compugen (Israel) (IL), Gates Foundation (US), United States Food and Drug Administration (US), Pfizer (United States) (US), Eastern Mennonite University (US), IQVIA (United Kingdom) (GB), Novavax (United States) (US), Mercy Willard Hospital (US), Moderna Therapeutics (United States) (US), Austrian Energy Agency (AT), AstraZeneca (Brazil) (BR), Merck Biopharma Co., Ltd. (Japan) (JP), Agência Nacional de Energia Elétrica (BR), Johnson & Johnson (Israel) (IL), Inovio Pharmaceuticals (United States) (US), Thermo Fisher Scientific (United States) (US), Sage Technologies (United States) (US), Montana Health Research Institute (US), OneVax (United States) (US), Takeda (France) (FR), GlaxoSmithKline (Netherlands) (NL), Wavefront Research (United States) (US), Thermo Fisher Scientific (Israel) (IL)
Openalex Percentile: Top 16%
Biosimilars and Bioanalytical Methods
DOISourceOpenAlex
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