Module 9 2021

22/03/2021

Learning Outcomes

What is immunogenicity? Why / when does it occur?

Strategy for immunogenicity assessment Screening & confirmatory immunoassays Neutralising antibody assays Issues & considerations Recommendations & Guidelines

The Organisation for Professionals in Regulatory Affairs

3

Definitions

Immunogenicity: ability of a particular substance to elicit an immune response. If there is an induced immune response in patient, the substance is said to be immunogenic, and is designated as the antigen. Immune response: humoral (production of antibodies) and/or cell-mediated. Epitope (determinant or antigenic determinant) : part of the antigen recognised by the immune system. Epitopes can be linear or conformational, and combine with the specific antibodies produced. Distinction between sought after immunogenicity (e.g., vaccines – inducing immune response aiming at protecting the individual) and unwanted immunogenicity (e.g., biotherapeutics - production of anti-drug antibodies or ADA).

The Organisation for Professionals in Regulatory Affairs

4

2