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Updated: Sep 10, 2025

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Immunogenicity Risk Assessment of Biotherapeutics Using an Ex Vivo B Cell Assay.

Kevin M Budge1, Ross Blankenship1, Patricia Brown-Augsburger1

  • 1Eli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN 46285, USA.

Antibodies (Basel, Switzerland)
|August 22, 2025
PubMed
Summary

Developing a B cell assay for predicting anti-drug antibody (ADA) formation in monoclonal antibodies (mAbs) is challenging. While B cells activated and secreted IgG, this did not correlate with clinical immunogenicity risk.

Keywords:
ADAB cellsanti-drug antibodiesantibodiesbiotherapeuticimmunogenicity

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Area of Science:

  • Biopharmaceutical development
  • Immunology
  • Drug safety

Background:

  • Anti-drug antibody (ADA) formation impacts biotherapeutic safety and efficacy.
  • Current immunogenicity risk prediction methods for monoclonal antibodies (mAbs) do not assess B cell responses.
  • B cells are professional antigen-presenting cells (APCs) and secrete antibodies, making their assessment crucial for comprehensive risk prediction.

Purpose of the Study:

  • To develop and evaluate a B cell-based assay for predicting immunogenicity risk of mAbs.
  • To assess the utility of B cell activation, proliferation, and IgG secretion as readouts for immunogenicity.

Main Methods:

  • Utilized a peripheral blood mononuclear cell (PBMC) culture system.
  • Supported B cell survival and activation using IL-4, IL-21, B cell activating factor (BAFF), and an anti-CD40 agonist mAb.
  • Screened 51 antibodies with known clinical immunogenicity rates.

Main Results:

  • Activated B cells proliferated and secreted IgG in the assay.
  • Observed differences in IgG secretion among tested antibodies.
  • IgG secretion levels did not correlate with the clinical immunogenicity ratings of the mAbs.

Conclusions:

  • Developing a robust B cell assay for mAb immunogenicity risk prediction presents significant challenges.
  • The study provides a foundational framework for refining B cell-based assays for more comprehensive immunogenicity risk assessment.
  • Further optimization is needed to correlate B cell responses with actual clinical outcomes.