Journal of Chromatography & Separation Techniques
Open Access

Richardson D

Publications

• 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

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