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Literature review in support of adjuvanticity/ immunogenicity assessment of proteins

On The Agenda
From: Antonio C.
Added: 11.04.2021
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BIO represents more than 1, biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. In general, the Draft Guidance is very well written and provides a useful review of the numerous factors that can affect immunogenicity. BIO generally agrees with the risk-based approach presented in the Draft Guidance but recommends that FDA set a minimum level of required immunogenicity testing for all therapeutic protein products to provide clarity for potential Sponsors and to ensure safety and efficacy for patients.

Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody

Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody | SpringerLink

Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have varied not only due to different degrees of understanding of product immunogenicity at the time of licensing but also due to an evolving lexicon that has generated some confusion in the field. In recent years, there has been growing consensus regarding the data needed to assess product immunogenicity. Harmonization of the strategy for the elucidation of product immunogenicity by drug developers, as well as the use of defined common terminology, can benefit medical practitioners, health regulatory agencies, and ultimately the patients. Clearly, understanding the incidence, kinetics and magnitude of anti-drug antibody ADA , its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and related clinical impact may enhance clinical management of patients treated with biologic drugs.

Immunogenicity Assessment

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: Kosti and M. Triga and S.
The response in the assay to 10 monoclonal antibodies was found to be in agreement with the clinical immunogenicity, suggesting that the assay might be applied to immunogenicity risk assessment of antibody biotherapeutic attributes. However, the response in the assay is a measure of T-cell functional activity and the alignment with clinical immunogenicity depends on several other factors. The assay was sensitive to sequence variants and could differentiate single point mutations of the same biotherapeutic.

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