Our Take

Perspectives on immunogenicity science, industry best practices, and the evolving regulatory landscape

We believe that immunogenicity risk assessment should be scientifically rigorous, contextually relevant, and practically actionable. Through our publications, presentations, and industry engagement, we work to advance the field and share insights that help development teams make better decisions.

Select Publications

Our peer-reviewed contributions focus on practical approaches to immunogenicity assessment that bridge scientific understanding with development decision-making.

The Immunogenicity Database Collaborative (IDC): A standardized public database for clinical immunogenicity.

Agnihotri S, Gonzalez-Nolasco B, Monian B, Pattijn S, Ackaert C, Wu P, Kettenberger H, Tourdot S, Hickling T, Hu Z, Higgs RE, Leventhal DS

bioRxiv, 2025

Introduction of a structured clinical immunogenicity dataset enabling systematic evaluation of drivers of ADA risk across biotherapeutics.

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T cell assays for non-clinical immunogenicity risk assessment: best practices recommended by the European Immunogenicity Platform.

Tourdot S, Karle AC, Rosenbaum M, Ackaert C, Le Vu P, Gutknecht M, Ahmadi M, Turksma AW, Hickling TP

Frontiers in Immunology, 2025

Provides best-practice guidance for designing and interpreting T cell assays used in non-clinical immunogenicity risk assessment, helping ensure robust and actionable data for candidate evaluation.

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Expanding the MAPPs assay to accommodate MHC-II pan receptors for improved predictability of T cell epitopes.

Hartman K, Steiner G, Siegel M, Looney CM, Hickling TP, Bray-French K

Biology, 2023

Describes improvements to the MAPPs assay that enhance detection of naturally presented peptides, strengthening its use for identifying potential T cell epitopes during immunogenicity risk assessment.

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Protein re-surfacing of E. coli L-asparaginase to evade pre-existing anti-drug antibodies and hypersensitivity responses.

Bootwala A, An HH, Franklin MW, Manning BJ, Xu LY, Panchal S, Garlick JD, Baral R, Hudson ME, Grigoryan G, Murakami MA, Hopson K, Leventhal DS

Frontiers in Immunology, 2022

Demonstrates how protein engineering can reduce recognition by pre-existing anti-drug antibodies, illustrating a practical strategy to mitigate immunogenicity risk during therapeutic protein design.

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Immunogenicity of immunomodulatory, antibody-based oncology therapeutics.

Davda J, Declerck P, Hu-Lieskovan S, Hickling TP, Jacobs IA, Chou J, Salek-Ardakani S, Kraynov E

Journal for ImmunoTherapy of Cancer, 2019

Reviews immunogenicity considerations for antibody-based oncology therapeutics and highlights factors that influence ADA risk and clinical impact across cancer immunotherapies.

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Presentations & Workshops

We regularly share our perspectives at industry conferences and through educational workshops, contributing to the broader conversation about immunogenicity best practices.

Conference Presentations

  • PepTalk - Daniel (Invited Speaker) and Tim (Featured Talk)
  • Immunogenicity and Bioassay Summit - Tim (Invited Speaker) and Dan (Invited Speaker and Panel Moderator)
  • European Immunogenicity Platform Annual Meeting - Tim (Invited Speaker) and Dan (Spotlight Presentation)
  • PEGS Boston - Dan (Invited Speaker) and Tim (Training Instructor)

Recent Topics

  • Tim - "Enabling Quality by Design in Therapeutic Protein Discovery and Development"
  • Dan - "Interpreting Clinical Immunogenicity Measures for AI/ML Risk Assessment"
  • Tim - "Novel assay to evaluate B-cell specific drug immunogenicity liabilities"
  • Dan - "What Can Human and Machine Learning Tell Us About Immunogenicity Risk"

Industry Engagement

We actively contribute to industry working groups and initiatives that shape immunogenicity best practices and regulatory guidance.

AAPS TPI Community

Leadership in the Immunogenicity Risk Assessment and Mitigation (IRAM) working group and active member in other specialized groups such as B cell immunogenicity and MAPPs.

European Immunogenicity Platform Community

Active membership in EIP working groups and contributors to industry review articles and best practices publications.

Industry Consortia

Formation of and leadership within cross-company initiatives addressing common immunogenicity challenges and developing harmonized approaches.

Our Philosophy

What We Believe

We believe that effective immunogenicity risk assessment is:

  • Hypothesis-driven — not a checklist exercise
  • Context-specific — considering molecule, indication, and patient population
  • Proactive — integrated early and updated throughout development
  • Actionable — leading to concrete development decisions

What the Field Needs

We see opportunities for the field to continue evolving:

  • Better integration of preclinical and clinical immunogenicity data
  • More nuanced risk frameworks for novel modalities
  • Improved translation of in silico predictions to clinical risk
  • Harmonized terminology and industry-wide collaboration

Let's Continue the Conversation

We're always interested in discussing immunogenicity challenges and opportunities. Reach out to explore how our perspectives might support your program.

Get in Touch