Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment

Recommendations for Preparation, Design, and Editing of Calibration Curves

Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling

Managing unwanted immunogenicity of therapeutic proteins

2016 White Paper, Recent Issues in Bioanalysis Part 3 – LBA, Biomarkers, and Immunogenicity

Humoral Immune Response to AAV

Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study

Analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study

B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera

The quintessence of immunogenicity reporting for biotherapeutics

Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

2014 White Paper on Recent Issues in Bioanalysis: A Full Immersion in Bioanalysis (Part 3 – LBA and Immunogenicity)

7th GCC Insights: Incurred samples use, solution stability, and more

Case Studies: Challenges of Supporting Comparability Work for Biosimilars

7th GCC Insights: incurred samples use; fitfor- Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

Recommendations on incurred sample stability (ISS) by GCC

Potential induction of anti-PEG antibodies – PEGylated therapeutics

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations

Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab

Immune responses to AAV vectors: overcoming barriers to successful gene therapy

Oncogenic Pim-3 Kinase Can Counteract Chemoresistance in Pancreatic Cancer

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development

Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis

In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes)

Biosimilars: what clinicians should know

Setting the stage for biosimilar monoclonal antibodies

6th GCC Focus on LBA: Critical Reagents, Positive Controls and Reference Standards; Specificity for Endogenous Compounds; Biomarkers; Biosimilars

Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

Recommendations on biomarker bioanalytical method validation by GCC

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

Immunogenicity assays and comparability studies in biosimilar drugs

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines

Recommendations on Bioanalytical Method Stability Implications of Co-Administered and Co-Formulated Drugs by Global CRO Council for Bioanalysis (GCC)

6th GCC – “Focus on Ligand-Binding Assays”

Recommendations on the Interpretation of the New European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process

Ligand Binding Assays: Recommendations for Characterization and Supply of Critical Reagents

Ligand Binding Assays in the 21st Century Laboratory: Automation

Ligand Binding Assays in the 21st Century Laboratory: Platforms

Recommendations on the Interpretation of the new EMA Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development