AN OVERVIEW OF BIOLOGICS: SCIENCE BEHIND PROTEIN THERAPEUTICS

Autor: Inderjeet Kaur, Manoj G Pillai, Nirpendra Singh
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Zdroj: Journal of Proteins and Proteomics, Vol 3, Iss 3, Pp 229-237 (2012)
ISSN: 0975-8151
Popis: Biosimilars or ‘follow-on biologics’ are new biopharmaceutical agents that are ‘similar’ but not identical to a reference biopharmaceutical product. Biosimilars are considered ‘comparable’ to the reference product, but this does not ensure therapeutic equivalence. Inherent differences between biosimilars may produce dissimilarities in clinical efficacy, safety, and immunogenicity. Therefore accurate measurement and characterization of these differences and absolute quantification of biosimilars is the significant requirement at present. Mass spectrometry coupled with high performance liquid chromatography offers the most sensitive and accurate solution for this. This review discusses the potential strategies for the absolute quantification of biosimilars using mass spectrometry.
Databáze: OpenAIRE