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Vaccinations

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Antigens Involved in Adaptive Immunity

Antigens Involved in Adaptive Immunity

An antigen is any substance the immune system identifies as foreign and potentially harmful to the body, prompting an immune response. Antigens have two functional properties: immunogenicity and reactivity. Immunogenicity is the ability of an antigen to stimulate a specific immune response. At the same time, reactivity describes the antigen's ability to react with the cells and antibodies produced in response to it.
Complete Antigens
Complete antigens possess both immunogenicity and...

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Developing a Salivary Antibody Multiplex Immunoassay to Measure Human Exposure to Environmental Pathogens

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IQ Survey Results on Current Industry Practices-Part 1: Immunogenicity Risk Assessment.

Christine Grimaldi¹, Susan Richards², Daniel Baltrukonis³

¹Bioanlytical Sciences, Regeneron, Inc, Tarrytown, New York, USA.

Clinical Pharmacology and Therapeutics

|January 29, 2025

Summary

This summary is machine-generated.

An immunogenicity risk assessment (IRA) is a key part of drug development. While companies have established IRA processes, especially for monoclonal antibodies, more experience is needed for novel therapeutic modalities.

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Area of Science:

Biopharmaceutical Development
Drug Safety and Risk Assessment
Immunology

Background:

Health authorities increasingly expect immunogenicity risk assessments (IRAs) in drug development.
IRAs involve evaluating product and patient factors to predict a biotherapeutic's immunogenic potential and plan actions.

Purpose of the Study:

To survey current practices for conducting IRAs and bioanalysis within the pharmaceutical/biotech industry.
To understand how companies approach immunogenicity risk assessment across various drug modalities.

Main Methods:

A survey was conducted by the IQ Consortium's Immunogenicity Working Group.
Responses were gathered from 19 IQ member companies, covering diverse drug types including monoclonal antibodies and novel modalities.

Main Results:

Most companies have defined IRA processes, acknowledging the need for flexibility as development progresses.
Variations exist in IRA implementation timelines, preclinical data usage, computational methods, and integration with clinical plans.
Extensive experience exists for monoclonal antibodies, but novel modalities require further IRA development.

Conclusions:

Companies generally have established IRA processes, with a consensus on their dynamic nature.
Significant experience exists for monoclonal antibodies, but novel therapeutic modalities present ongoing challenges for comprehensive immunogenicity risk assessment.