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Challenges in developing antidrug antibody screening assays.

Robert Dodge1, Caroline Daus, Dania Yaskanin

  • 1Taylor Technology, Pharmanet Development Group, Princeton, NJ, USA. rdodge@pharmanet.com

Bioanalysis
|November 19, 2010
PubMed
Summary

Developing antidrug antibody (ADA) screening assays presents unique challenges. These assays are crucial for protein drug safety and efficacy, requiring careful consideration during development.

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Area of Science:

  • Immunochemistry
  • Bioanalytical Chemistry
  • Pharmacology

Background:

  • Protein drugs can trigger an immune response, leading to antidrug antibodies (ADAs).
  • ADA responses can have significant safety implications and affect drug efficacy.
  • Bioanalytical testing for ADAs is a regulatory requirement for protein drug safety evaluations.

Purpose of the Study:

  • To review the unique challenges encountered during the development of antidrug antibody (ADA) assays.
  • To highlight the differences between ADA screening assays and standard immunoassays.

Main Methods:

  • Review of regulatory guidance and scientific white papers on tiered approaches for ADA testing.
  • Discussion of the characteristics of ADA screening assays, including their quasiquantitative nature and lack of specific positive controls.

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  • Examination of the design requirements for detecting multiple antibody isotypes and subclasses.

    • Main Results:

    • ADA screening assays are quasiquantitative and typically lack specific positive controls.
    • These assays must be designed to detect a wide range of antibody isotypes and subclasses.
    • The characteristics of ADA screening assays differ significantly from standard protein quantitation immunoassays.

    Conclusions:

    • The development of effective ADA screening assays involves overcoming specific challenges.
    • Understanding these challenges is critical for ensuring the safety and efficacy of protein drugs.
    • A tiered approach, starting with a robust screening assay, is recommended for ADA testing.