Harmonization of Vaccine Ligand Binding Assays Validation

The urgency and importance of organizing a global effort to harmonize clinical assay validation specific to the vaccine industry was identified during the drafting of the 2020 White Paper in Bioanalysis due to the lack of clarity and regulatory guidance/guidelines in vaccine immunoassay validation. Indeed, the Workshop on Recent Issues in Bioanalysis (WRIB) issues the White Paper in Bioanalysis yearly, which is one of the high-profile articles of the <i>Bioanalysis</i> Journal focused on detailed discussions and recommendations on vaccine assay validation. 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. Using industry and WRIB vaccine network, a vaccine immunogenicity assay validation working group was assembled consisting of 16 companies. The work on the first white paper started officially in April 2021 focusing on Vaccine LBA Validation (Part 1), and the drafting of Vaccine LBA Development (Part 2) and Vaccine LBA Monitoring & Transfer (Part 3) are presently ongoing and expected to be published shortly after this paper. Moreover, recommendations on Vaccine Cell-Based Assays Validation (ELISpot and Flow cytometry) and Vaccine Molecular Assays Validation (PCR, NGS, NanoString) are also on the WRIB publications agenda and the drafting is planned to start in mid-2024. For too long, vaccine scientists have not had a clear validation guidance for clinical vaccine immunogenicity assays. We hope that this common effort will help close this regulatory gap.

Authors

Institutions

Publication Details

Journal
Bioanalysis
Published
2024-10-17
DOI
https://doi.org/10.1080/17576180.2024.2411925
Citations
3
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.72

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Harmonization of Vaccine Ligand Binding Assays Validation

Alessandra Buoninfante, Louis Fries, Rocio Murphy, Katrina M. Nolan et al.
3 citations
Bioanalysis
Biosimilars and Bioanalytical Methods
0.72
article

Harmonization of Vaccine Ligand Binding Assays Validation

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

Abstract

The urgency and importance of organizing a global effort to harmonize clinical assay validation specific to the vaccine industry was identified during the drafting of the 2020 White Paper in Bioanalysis due to the lack of clarity and regulatory guidance/guidelines in vaccine immunoassay validation. Indeed, the Workshop on Recent Issues in Bioanalysis (WRIB) issues the White Paper in Bioanalysis yearly, which is one of the high-profile articles of the <i>Bioanalysis</i> Journal focused on detailed discussions and recommendations on vaccine assay validation. 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. Using industry and WRIB vaccine network, a vaccine immunogenicity assay validation working group was assembled consisting of 16 companies. The work on the first white paper started officially in April 2021 focusing on Vaccine LBA Validation (Part 1), and the drafting of Vaccine LBA Development (Part 2) and Vaccine LBA Monitoring & Transfer (Part 3) are presently ongoing and expected to be published shortly after this paper. Moreover, recommendations on Vaccine Cell-Based Assays Validation (ELISpot and Flow cytometry) and Vaccine Molecular Assays Validation (PCR, NGS, NanoString) are also on the WRIB publications agenda and the drafting is planned to start in mid-2024. For too long, vaccine scientists have not had a clear validation guidance for clinical vaccine immunogenicity assays. We hope that this common effort will help close this regulatory gap.

BioanalysisVol. 16(19-20)
Pharmaceutical Product Development (United States) (US), Gates Foundation (US), United States Food and Drug Administration (US), Pfizer (United States) (US), United States Military Academy (US), Takeda (Switzerland) (CH), GlaxoSmithKline (Belgium) (BE), Novavax (United States) (US), Moderna Therapeutics (United States) (US), Sanofi (United States) (US), Inovio Pharmaceuticals (United States) (US), Takeda (United States) (US), AstraZeneca (United States) (US), Anis (BR), General Electric (Norway) (NO), Janssen (Netherlands) (NL)
Sanofi, Ministry of Health, Labour and Welfare, U.S. Food and Drug Administration, Health Canada
Zero hunger
Openalex Percentile: Top 28%
Biosimilars and Bioanalytical Methods
0.72
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.