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Related Experiment Video

Updated: Oct 11, 2025

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
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Anti-drug Antibody Validation Testing and Reporting Harmonization.

Heather Myler1, João Pedras-Vasconcelos2, Kelli Phillips3

  • 1Immunochemistry Department, PPD Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA. Heather.Myler@ppdi.com.

The AAPS Journal
|December 2, 2021
PubMed
Summary
This summary is machine-generated.

Harmonized tools for immunogenicity assay validation testing and reporting were developed to reduce health authority queries. These strategies address assay performance, sensitivity, specificity, and sample handling for smoother drug development filings.

Keywords:
Anti-drug antibodies (ADA)FDAImmunogenicityNeutralizing antibodies (NAb)Regulatory guidanceValidation

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Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Immunology

Background:

  • Evolving immunogenicity assay performance standards and inconsistent validation practices create challenges for regulatory submissions.
  • Significant time is currently spent by health authorities and pharmaceutical sponsors addressing queries related to anti-drug antibody (ADA) testing.
  • A collaborative group was formed to address these critical gaps in ADA assay validation and reporting.

Purpose of the Study:

  • To develop harmonized tools and strategies for immunogenicity assay validation and reporting.
  • To facilitate smoother filings to health authorities by providing industry scientists with practical guidance.
  • To address specific gaps in understanding immunogenicity assay requirements.

Main Methods:

  • A multidisciplinary team of 44 members from 29 organizations, including regulatory agencies and industry, collaborated over three years.
  • The group discussed and identified key gaps in immunogenicity assay requirements and validation.
  • Development of practical testing and reporting strategies and tools for various assay assessments.

Main Results:

  • Provided comprehensive testing and reporting strategies for critical assay parameters.
  • Included guidance on pre-study and in-study cut points, system suitability, assay sensitivity, and specificity.
  • Addressed sample stability, matrix effects, domain specificity for complex biologics, and titer reporting methods.

Conclusions:

  • The developed harmonization tools aim to standardize immunogenicity assay validation and reporting.
  • Implementation of these strategies is expected to reduce regulatory filing queries and streamline drug development.
  • This work provides a valuable resource for scientists navigating immunogenicity assay requirements.