[PDF] Guideline on immunogenicity assessment of biotechnology-derived

What does immunogenicity mean?

For the purposes of this guidance, immunogenicity is defined as the propensity of the therapeutic protein product to generate immune responses to itself and to related proteins or to induce immunologically related adverse clinical events.

What is immunogenicity in therapeutic proteins?

5 • In the context of Therapeutic Proteins product, immunogenicity refers to the immune response of the host against the Therapeutic Protein • The immunogenic response generally includes both cellular (T cell) and humoral (antibody) arms of the immune response, however we usually measure antibodies.

What is the goal of immunogenicity studies?

The goal of immunogenicity studies is to investigate presence of an immune response to the therapeutic protein and its clinical impact. Thus, the evaluation of immunogenicity should be based on integrated analysis of immunological, pharmacokinetic, pharmacodynamic, as well as clinical efficacy and safety data.

How do I discuss an alternative approach to immunogenicity testing?

To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. This guidance provides recommendations to facilitate industry’s development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials.