Journal of Chromatography & Separation Techniques
Open Access
ISSN: 2157-7064
+44 1300 500008
ISSN: 2157-7064
+44 1300 500008
Chen Z
Sterile Product and Analytical Development, Merck Research Laboratories,
Kenilworth, NJ
Tanzania
Research Article
Forced Degradation Study of Monoclonal Antibody Using Two-Dimensional Liquid Chromatography
Author(s): An Y, Verma S, Chen Y, Yu S, Zhang Y, Kelner S, Mengisen S, Richardson D and Chen ZAn Y, Verma S, Chen Y, Yu S, Zhang Y, Kelner S, Mengisen S, Richardson D and Chen Z
Monoclonal antibody (mAb) products are extraordinarily heterogeneous due to the presence of a variety of enzymatic and chemical modifications, such as deamidation, isomerization, oxidation, glycosylation, glycation, terminal cyclization, aggregation, and fragmentation. Forced degradation study is a common practice to assess the potential modifications and degradation pathways of mAbs upon extreme conditions, including light exposure and extreme local pH. The degraded samples are subject to characterization using a wide array of analyses, including ion exchange chromatography (IEC) for charge variants and size exclusion chromatography (SEC) for size variants. In this proof-of-concept study, a two-dimensional liquid chromatography (2D-LC) approach was successfully applied to mAb forced degradation samples for evaluation of size distribution in the IEC charge profile. The charge variant .. View More»
DOI:
10.4172/2157-7064.1000365