Two-Dimensional Liquid Chromatography (2D-LC): Analysis of Size-Based Heterogeneities in Monoclonal Antibody–Based Biotherapeutic Products

Autor:	Sanghati Bhattacharya, Deepika Sarin
Rok vydání:	2022
Předmět:	Analytical Chemistry
Zdroj:	LCGC North America. :27-31
ISSN:	1939-1889 1527-5949
DOI:	10.56530/lcgc.na.cz9881a2
Popis:	Monoclonal antibodies (mAbs) dominate the pipelines in the biopharmaceutical industry today. Being complex products, this class of molecules has numerous critical quality attributes (CQAs). Their thorough characterization is a necessary and critical component of biopharmaceutical product development. One CQA is size-based heterogeneity. Aggregates are widely considered a CQA because of their likely impact on the immunogenicity of the product. There is no single analytical tool that can accurately characterize aggregates because of the significant diversity that they exhibit with respect to size, structure, and morphology. As a result, it is common practice to use multiple, orthogonal analytical tools for aggregate characterization. This article reviews efforts targeting the use of two-dimensional liquid chromatography (2D-LC) and mass spectrometry (MS) for aggregate characterization.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::5200f4d98f3e4e67aba7e969730f8af3 https://doi.org/10.56530/lcgc.na.cz9881a2 Zobrazit plný text záznamu