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Updated: Jul 24, 2025

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

Heather Myler1,2, João Pedras-Vasconcelos3, Todd Lester4

  • 1Bioanalytical and Biomarker Science and Technologies, Takeda, Cambridge, MA, 02139, USA. heather.myler@takeda.com.

The AAPS Journal
|July 8, 2023
PubMed
Summary
This summary is machine-generated.

Harmonizing immunogenicity assay validation and reporting for neutralizing antibodies streamlines health authority filings. This guidance addresses key assay performance and reporting challenges for both cell-based and non-cell-based methods.

Keywords:
FDAanti-drug antibodies (ADA)immunogenicityneutralizing antibodies (NAb)regulatory guidancevalidation

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Area of Science:

  • Biopharmaceutical Development
  • Immunology
  • Analytical Chemistry

Background:

  • Evolving immunogenicity assay performance standards and inconsistent validation tools create regulatory hurdles.
  • Significant time is lost by health authorities and sponsors resolving queries related to neutralizing antibody assay filings.

Purpose of the Study:

  • To provide harmonized validation testing and reporting strategies for neutralizing antibody assays.
  • To address challenges specific to cell-based and non-cell-based immunogenicity assays.
  • To facilitate smoother regulatory filings with health authorities.

Main Methods:

  • Expert consensus from industry and FDA within the American Association of Pharmaceutical Scientists' Therapeutic Product Immunogenicity Community.
  • Development of strategies and tools for critical assay validation parameters.
  • Focus on both cell-based and non-cell-based neutralizing antibody assay assessments.

Main Results:

  • Detailed guidance on 11 key validation aspects, including format selection, cut point determination, and assay acceptance criteria.
  • Strategies for assessing control precision, sensitivity, and specificity.
  • Considerations for drug and target tolerance, sample stability, and assay robustness.

Conclusions:

  • Harmonized validation expectations and data reporting are crucial for efficient regulatory submissions.
  • The proposed strategies and tools offer a framework for consistent immunogenicity assay evaluation.
  • Implementation will reduce filing queries and accelerate therapeutic product development.