Immunogenicity testing of new biologicals as part of safety studies

Biologicals used as therapeutics may induce unwanted immune responses in treated patients. Thus, the EMEA has recently issued a guideline for immunogenicity assessment. Immunogenicity testing should be part of clinical efficacy and safety studies.

Key elements of the EMEA recommendations in brief: Immunogenicity should be evaluated in all study participants and not only in symptomatic individuals. Bioassays for neutralizing antibodies need to be designed in a product-dependent manner. Clear criteria have to be defined to distinguish positive from negative findings and to confirm positive results.

FOCUS Immunology supports its clients to integrate these recommendations into their repsective clinical trial protocols. FOCUS’ services comprise assay development and validation for preclinical and clinical studies, testing under GLP conditions, implementation of confirmatory assays, development of bioassays for testing of neutralising antibodies and sample logistics in international multicenter trials.

If you have questions or want to discuss immunogenicity testing in your specific development project, please do not hesitate to contact our Head of the Immunology Laboratory Dr. Eddy Bruyns via email (eddy.bruyns@focus-cdd.com) or via telephone (+49 6221 649 35 124).

The current EMEA guideline on immunogenicity testing can be found here.