2024 White Paper in Bioanalysis 
This 2024 White Paper encompasses recommendations emerging from the extensive discussions held during the 18th WRIB in San Antonio, TX, USA on May 6-10, 2024 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 2024 edition of this comprehensive White Paper has been divided into three parts for editorial reasons and published on the Bioanalysis Journal (Taylor & Francis Group, UK).

• Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry
  • Part 1A – Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis
  • Part 1B – Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV
• Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA
  • Part 2A – Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA)
  • Part 2B – Regulatory Agencies’ Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)
• Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation
  • Part 3A – Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance
  • Part 3B – Regulatory Agencies’ Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies

WRIB Special Focus White Paper on 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. 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. This White Paper is the first global effort to guide vaccine clinical assay validation work. 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

• Harmonization of Vaccine Ligand Binding Assays Validation”

2023 White Paper in Bioanalysis 
This 2023 White Paper encompasses recommendations emerging from the extensive discussions held during the 17th WRIB in Orlando, FL, USA on June 19-23, 2023 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 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons and published on the Bioanalysis Journal (Taylor & Francis Group, UK).

• Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody
  • Part 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis
  • Part 1B – Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine
• EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccine
  • Part 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies
• ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard
  • Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization

2022 White Paper in Bioanalysis 
was based on the conclusions and consensus points from the 16th WRIB in September 2022 in Atlanta. It was divided into 3 parts due to length, and was published on the Bioanalysis Journal (Future Science, UK).

• ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs
  • Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization
  • Part 1B – Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine
• Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles
  • Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization
• FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays
  • Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach

2021 White Paper in Bioanalysis 
was based on the conclusions and consensus points from the 15th WRIB in September 2021. It was divided into 3 parts due to length, and was just published on the Bioanalysis Journal (Future Science, UK).

• Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices
  Regulatory Inputs
  • Part 1A – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC
  • Part 1B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine
• ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry
  • Part 2 – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation
• TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness
  • Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization

2020 White Paper in Bioanalysis 
was based on the conclusions and consensus points from the 14th WRIB in June 2020. It was divided into 3 parts due to length, and was just published on the Bioanalysis Journal (Future Science, UK).

• BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome
  • Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos
• BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF
  Regulatory Feedback
  • Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation
  • Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine
• Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation
  • Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays

2019 White Paper in Bioanalysis, Biomarkers, Immunogenicity and Gene Therapy 
was based on the conclusions and consensus points from the 13th WRIB in April 2019 in New Orleans. It was divided into 3 parts due to length, and was just published on Journal Bioanalysis.

• Part 1 – Chromatographic Assays - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis
• Part 2 – FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies’ Input on Bioanalysis, Biomarkers and Immunogenicity
• Part 3 – FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62

2018 White Paper in Bioanalysis, Biomarkers and Immunogenicity 
was based on the conclusions and consensus points from the 12th WRIB in April 2018 in Philadelphia. It was divided into 3 parts due to length, and was published on Journal Bioanalysis.

• Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis - A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)
• Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity - focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback
• Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays - focus on flow cytometry, gene therapy, cut points and key clarifications on BAV

2017 White Paper in Bioanalysis, Biomarkers and Immunogenicity 
was based on the conclusions and consensus points from the 11th WRIB in April 2017 in Los Angeles. It was divided into 3 parts due to length, and was published on Journal Bioanalysis.

• Part 1: SM, Peptides and SM Biomarkers by LCMS - Aren’t BMV Guidance “Scientific”
• Part 2: Hybrid LBA/LCMS and Inputs from Regulatory Agencies - Rise of the Hybrid LBA/LCMS Immunogenicity Assays
• Part 3: Immunogenicity, Biomarkers and PK Assays - A Global Perspective on Immunogenicity Guidelines & Biomarker Assays Performance

Decennial Index of all the recommendations from the last 10 years' WRIB White Papers to help you search easily by topics and see the evolution of the recommendations on the same topic over the years.

• The Decennial Index of the White Papers in Bioanalysis: “A Decade of Recommendations (2007–2016)”
  Note: you must save the pdf file to your computer then re-open it from your computer in order to activate the search functions in the pdf.

2016 White Paper in Bioanalysis: Focus on Biomarker Assay Validation (BAV) from the 10^th WRIB in April 2016 in Orlando. It was divided into 3 parts due to length.

• Part 1 – Small Molecules, Peptides and Small Molecule Biomarkers by LCMS - Bioanalysis (2016) 8(22), 2363–2378
• Part 2 – Hybrid LBA/LCMS and Inputs from Regulatory Agencies - Bioanalysis (2016) 8(23), 2457–2474
• Part 3 – LBA, Biomarkers, and Immunogenicity - Bioanalysis (2016) 8(23), 2475–2496

2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies & Biomarkers
was based on the conclusions and consensus points from the 9^th WRIB in April 2015 in Miami. It was divided into 3 parts due to length to be published on Journal Bioanalysis.

• Part 1 – Small Molecules by LCMS
• Part 2 – Hybrid LBA/LCMS and Inputs from Regulatory Agencies
• Part 3 – LBA, Biomarkers, and Immunogenicity

2014 White Paper on Recent Issues in Bioanalysis: A Full Immersion in Bioanalysis 
was based on the conclusions and consensus points from the 8th WRIB in March 2014 in Los Angeles. It was divided into 3 parts due to length, and was published on the Bioanalysis Journal (Future Science, UK).

• Part 1 – Small Molecules by LCMS
• Part 2 – Hybrid LBA/LCMS, ELN and Regulatory Agencies' Input
• Part 3 – LBA & Immunogenicity