[Biosimilar monoclonal antibodies: comparative study of analytical and functional quality].
Anticorps monoclonaux biosimilaires - Étude comparative des qualités analytique et fonctionnelle.
Journal
Medecine sciences : M/S
ISSN: 1958-5381
Titre abrégé: Med Sci (Paris)
Pays: France
ID NLM: 8710980
Informations de publication
Date de publication:
Dec 2019
Dec 2019
Historique:
entrez:
7
1
2020
pubmed:
7
1
2020
medline:
23
6
2020
Statut:
ppublish
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. Anticorps monoclonaux biosimilaires - Étude comparative des qualités analytique et fonctionnelle. La mise sur le marché de biosimilaires requiert une démonstration stricte de la similarité avec l’anticorps de référence, au travers d’études précliniques et cliniques. Cet article synthétise l’ensemble des analyses physicochimiques et fonctionnelles mises en œuvre in vitro, préalables à la réalisation d’études cliniques. Pour chaque caractéristique critique de l’anticorps, nous avons détaillé les techniques analytiques communément employées, leur principe de fonctionnement, ainsi que le type d’informations que ces techniques permettent d’obtenir.
Autres résumés
Type: Publisher
(fre)
Anticorps monoclonaux biosimilaires - Étude comparative des qualités analytique et fonctionnelle.
Identifiants
pubmed: 31903929
doi: 10.1051/medsci/2019215
pii: msc190048
doi:
Substances chimiques
Antibodies, Monoclonal
0
Biosimilar Pharmaceuticals
0
Types de publication
Comparative Study
Journal Article
Review
Langues
fre
Sous-ensembles de citation
IM
Pagination
1146-1152Informations de copyright
© 2019 médecine/sciences – Inserm.
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