Biosimilar Monoclonal Antibodies: Comparative Study of Analytical and Functional Quality
Anticorps monoclonaux biosimilaires Étude comparative des qualités analytique et fonctionnelle
Résumé
Biosimilars marketing authorization requires a strict demonstration of similarity with the reference antibody, through preclinical and clinical studies. This article reviews the panel of in vitro physicochemical and functional analyses, which are performed prior to clinical studies. For each critical attribute of the antibody, we detail the commonly used analytical techniques, their working principle and the type of information they may give.
Domaines
Médicaments
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