Health AI Central
Peer-Reviewed Publication
Front Immunol2026;171816949.January 1, 2026Journal Article

The immunogenicity database collaborative: a standardized, publicly available database for clinical immunogenicity observations and insights.

Sudhanshu Agnihotri1, Bruno Gonzalez-Nolasco2,3, Brinda Monian3, Sofie Pattijn4, Chloé Ackaert4, Patrick Wu5, Hubert Kettenberger6, Sophie Tourdot7, Timothy Hickling8,9, Zicheng Hu5, Richard E Higgs10, Daniel S Leventhal3,11,12
1Department of Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, United States.
2Early Development Services, Lonza Biologics Inc., Cambridge, MA, United States.
3Generate Biomedicines, Somerville, MA, United States.
4In Vitro Immunology, IQVIA Laboratories, Gosselies, Belgium.
5Department of Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc, South San Francisco, CA, United States.
6Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, Germany.
7Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Andover, MA, United States.
8Pharma Research and Early Development, Roche Innovation Centre Welwyn, Roche, Welwyn Garden City, United Kingdom.
9Quasor Ltd., Loughborough, England, United Kingdom.
10Eli Lilly and Company, Indianapolis, IN, United States.
11Xaira Therapeutics, South San Francisco, CA, United States.
12Tactyl LLC, St. Petersburg, FL, United States.
PubMed PMC DOI PDF

Abstract

Anti-drug antibodies (ADAs) against biotherapeutics remain difficult to predict, limiting efforts to assess and mitigate immunogenicity risk prior to clinical development. Existing immunogenicity data are fragmented across disparate sources and reported using inconsistent definitions, creating a major barrier to understanding the drivers of ADA formation. To address this challenge, we established…

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