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Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development

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Immunogenicity assessment in non-clinical studies.

Steven J Swanson¹, Jeanine Bussiere

¹Clinical Immunology, Amgen, Inc., Thousand Oaks, CA 91320, United States. swanson@amgen.com

Current Opinion in Microbiology

|July 10, 2012

Summary

Preclinical anti-drug antibody testing for protein therapeutics is not always necessary. Data from these studies may not predict clinical immunogenicity but can aid in interpreting other safety data when needed.

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Area of Science:

Biopharmaceutical development
Drug safety evaluation
Immunogenicity assessment

Background:

International Council for Harmonisation S6 guidance suggests anti-drug antibody (ADA) testing is not always required for protein therapeutic safety.
High drug concentrations in preclinical studies can interfere with ADA detection.
Preclinical ADA responses do not reliably predict clinical immunogenicity.

Purpose of the Study:

To evaluate the necessity and utility of preclinical anti-drug antibody testing for biopharmaceuticals.
To discuss the interpretation and limitations of immunogenicity data in preclinical drug development.
To highlight potential safety concerns related to immune complex formation.

Main Methods:

Review of current regulatory guidance (ICH S6).
Discussion of analytical procedures for ADA detection (immunoassays, biological assays).
Consideration of immune complex formation and its safety implications.

Main Results:

Preclinical ADA testing is not universally required.
ADA detection can be challenging due to high drug levels.
Preclinical immunogenicity data has limited predictive value for clinical outcomes.
Certain conditions, like IV mAb dosing, can lead to safety issues via immune complexes.

Conclusions:

Preclinical ADA testing should be selectively applied based on specific study needs.
The primary value of preclinical immunogenicity data lies in interpreting other study findings.
Understanding potential safety risks, such as immune complex formation, is crucial.