2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometr

The 19<sup>th</sup> Workshop on Recent Issues in Bioanalysis (19<sup>th</sup> WRIB) took place in New Orleans, LA, USA on April 7-11, 2025. Over 1200 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 19<sup>th</sup> WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.Moreover, in-depth workshops on "Implementation Practice for the Newest ELN/LIMS Systems" and on "Vaccine Cell-Based/Functional & Molecular Assays as part of the harmonization of vaccine clinical assays global initiative" were the special features of the 19<sup>th</sup> edition.As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and Regulatory Agency experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues.This 2025 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2025 edition of this comprehensive White Paper has been divided into three parts for editorial reasons.This publication (Part 2) covers in the Part 2A the recommendations on Biomarkers/BAV, IVD/CDx, Ligand-Binding Assays and Cell-Based Assays and in Part 3B the Regulatory Inputs on these topics. Part 1 (Mass Spectrometry Assays and Regulated Bioanalysis/BMV) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 18 of Bioanalysis, issues 3 and 1 (2026), respectively.

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Journal
Bioanalysis
Published
2025-12-02
DOI
https://doi.org/10.1080/17576180.2025.2599698
Citations
1
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.80
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2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometr

Christine Grimaldi, Rachel Palmer, Enrique Gómez Alcaide, Alessandra Buoninfante et al.
1 citations
Bioanalysis
Biosimilars and Bioanalytical Methods
0.80
article

2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometr

Christine Grimaldi, Rachel Palmer, Enrique Gómez Alcaide, Alessandra Buoninfante, Karl Walravens, G C H Sanderink, Anna Nowocin, Erin Stevens, Sally Fischer, James W. Huleatt, Kristina McGuire, Alison Joyce, Sandra Prior, João Tavares Neto, Bradley J. Scott, Christopher Beaver, Fred McCush, Andrei Avanesov, Paul C. Trampont, Xiaodong Fang, Binsheng Gong, Vilma Decman, Sarah Hersey, Catherine L Brockus, Jeroen Stoop, Kelly Coble, A. Seyda, Yongliang Sun, Chad Stevens, Michael N. Hedrick, Kimberly J. Reese, Liching Cao, Jad Zoghbi, Sarah Bond, Polina Goihberg, Ingrid L. Scully, Fabio Garofolo, Graham Yearwood, Mark Dysinger, Abbas Bandukwala, K Wang, Thorsten Verch, Claire Kerridge, Amanda Hays, Nathan Standifer, Nicoletta Bivi, Kun Lu, Rashmi Jalah, Michele Gunsior, W C Xiao, Chad R. Irwin, Sarita Sehra, Kamala Bhavaraju, Shannon McGrath, Francis Dessy, Kay-Gunnar Stubenrauch, Brian Baker, Christian Mayer, Lindsay King, Huaping Tang, Corinne Petit-Frere, Saleem Shaik, William Ogorman, Steven Eck, Emily Gomme, Liang Zhu, Katrina Nolan, Alexander Braun, Yong Jiang, Ellen O’ Connor, Soma Ray, Carrie Rubel, Jessica McGregor, Melis McHenry, Luis Mendez
article en
1 citations

Abstract

The 19<sup>th</sup> Workshop on Recent Issues in Bioanalysis (19<sup>th</sup> WRIB) took place in New Orleans, LA, USA on April 7-11, 2025. Over 1200 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 19<sup>th</sup> WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.Moreover, in-depth workshops on "Implementation Practice for the Newest ELN/LIMS Systems" and on "Vaccine Cell-Based/Functional & Molecular Assays as part of the harmonization of vaccine clinical assays global initiative" were the special features of the 19<sup>th</sup> edition.As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and Regulatory Agency experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues.This 2025 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2025 edition of this comprehensive White Paper has been divided into three parts for editorial reasons.This publication (Part 2) covers in the Part 2A the recommendations on Biomarkers/BAV, IVD/CDx, Ligand-Binding Assays and Cell-Based Assays and in Part 3B the Regulatory Inputs on these topics. Part 1 (Mass Spectrometry Assays and Regulated Bioanalysis/BMV) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 18 of Bioanalysis, issues 3 and 1 (2026), respectively.

BioanalysisVol. 17(23)
Gates (United States) (US), Roche (Switzerland) (CH), Health Canada (CA), Biogen (United States) (US), United States Food and Drug Administration (US), Alnylam Pharmaceuticals (United States) (US), Bristol-Myers Squibb (Germany) (DE), Dr. Reddy's Laboratories (United States) (US), Eli Lilly (United States) (US), Daiichi Sankyo (Germany) (DE), Pfizer (United States) (US), Regeneron (United States) (US), Eastern Mennonite University (US), European Institute for Advanced Studies in Management (BE), Sanofi (France) (FR), AskBio (United States) (US), Moderna Therapeutics (United States) (US), Tempest Technologies (United States) (US), Austrian Energy Agency (AT), AstraZeneca (Brazil) (BR), Vyne Therapeutics (United States) (US), Merck Biopharma Co., Ltd. (Japan) (JP), Boehringer Ingelheim (Egypt) (EG), Alexion Pharmaceuticals (United States) (US), Agência Nacional de Energia Elétrica (BR), Johnson & Johnson (Israel) (IL), Daiichi-Sankyo (South Korea) (KR), Sangamo BioSciences (United States) (US), Sage Technologies (United States) (US), Intralytix (United States) (US), Montana Health Research Institute (US), Takeda (France) (FR), GlaxoSmithKline (Netherlands) (NL), Roche (Sweden) (SE), Wavefront Research (United States) (US), Fresenius Kabi (Czechia) (CZ), Incyte (United States) (US)
Industry, innovation and infrastructure
Openalex Percentile: Top 20%
Biosimilars and Bioanalytical Methods
0.80
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