Anti Drug Antibody Sample Testing and Reporting Harmonization
The Critical Need for Reporting Harmonization
A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting. Standardizing this process facilitates clearer communication of findings and supports an expedient review by both industry and health authorities.
To address key gaps in bioanalytical reporting, a cross-industry group was formed to establish harmonized recommendations. This white paper provides these recommendations and a submission template to streamline agency filings for ligand-binding assay technologies.
What You Will Learn
This white paper delivers expert recommendations and a structured template for reporting clinical anti-drug antibody (ADA) results, focusing on essential bioanalytical report (BAR) elements.
Key Learnings:
- Essential Bioanalytical Report (BAR) Elements: Gain a comprehensive understanding of the critical components for your BAR, including method, reagents, equipment, study samples, results, and data analysis.
- Harmonized Recommendations: Access insights from a cross-industry group on best practices for documenting and presenting immunogenicity results.
- Submission-Ready Template: Utilize a suggested structure for the ADA BAR designed to streamline regulatory filings and improve clarity.
Note: This publication focuses on the content and presentation of the bioanalytical ADA sample analysis report. The interpretation of immunogenicity data, including the impact of ADA on safety and efficacy, is outside the scope of this document.
Secure Your Complimentary Whitepaper Today
Access expert guidance and a practical template to enhance the clarity and efficiency of your immunogenicity reporting.