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Related Experiment Video

Updated: Jan 26, 2026

Preparation of Mouse Pituitary Immunogen for the Induction of Experimental Autoimmune Hypophysitis

Preparation of Mouse Pituitary Immunogen for the Induction of Experimental Autoimmune Hypophysitis

Published on: December 17, 2010

Report on the AAPS Immunogenicity Guidance Forum.

Heather Myler¹, Boris Gorovits², Kelli Phillips³

¹Immunochemistry Department, PPD Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA. Heather.Myler@ppdi.com.

The AAPS Journal

|April 18, 2019

Summary

This forum discussed immunogenicity testing for therapeutic proteins, focusing on anti-drug antibody (ADA) assay strategies, cut-point assessments, and positive control performance to ensure drug safety and efficacy.

Keywords:

Anti-drug antibodies (ADA)FDA guidance Immunogenicity Neutralizing antibodies (NAb)

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Area of Science:

Biopharmaceutical Science
Drug Development
Immunology

Background:

The American Association of Pharmaceutical Scientists (AAPS) Annual Guidance Forum convened in September 2018.
The forum addressed critical aspects of immunogenicity testing for therapeutic protein products.
Key participants included representatives from the pharmaceutical industry and the US Food and Drug Administration (FDA).

Purpose of the Study:

To present and discuss updated guidance on immunogenicity testing for therapeutic proteins.
To share perspectives from both regulatory agencies (FDA) and the pharmaceutical industry.
To deliberate on specific strategies for anti-drug antibody (ADA) assay development and validation.

Main Methods:

Discussion-based forum involving experts from industry and regulatory bodies.
Presentation of agency and industry viewpoints on current guidance.
Focused sessions on critical assay parameters and their assessment.

Main Results:

Exploration of strategies for anti-drug antibody (ADA) assay cut-point assessments.
Discussion on the selection and performance evaluation of ADA-positive controls (PCs).
Consideration of ADA assay attributes, including drug tolerance and sensitivity.

Conclusions:

The forum highlighted the importance of robust immunogenicity testing strategies for therapeutic proteins.
Consensus and differing perspectives were shared regarding ADA assay cut-point setting and control performance.
The discussions aimed to refine best practices for ensuring the safety and efficacy of protein-based therapeutics.