Validation of a pH gradient-based ion-exchange chromatography method for high-resolution monoclonal antibody charge variant separations

Journal of Pharmaceutical and Biomedical Analysis

Volumn 54, Issue 2, 2011, Pages 317-323

  Rea, Jennifer C ^a   Moreno, G Tony ^a   Lou, Yun ^a   Farnan, Dell ^a  

^a GENENTECH INC   (United States)

Author keywords

Antibodies; Charge heterogeneity; Ion exchange chromatography; Method validation; Monoclonal; PH gradient

Indexed keywords

BUFFER; MONOCLONAL ANTIBODY; SODIUM CHLORIDE;

ACCURACY; ARTICLE; CAPILLARY ISOELECTRIC FOCUSING; ION EXCHANGE CHROMATOGRAPHY; PH; PRIORITY JOURNAL; TEMPERATURE; TEMPERATURE STRESS; VALIDATION PROCESS;

ANTIBODIES, MONOCLONAL; BUFFERS; CHROMATOGRAPHY, ION EXCHANGE; HOT TEMPERATURE; HYDROGEN-ION CONCENTRATION; ISOELECTRIC FOCUSING; PROTON-MOTIVE FORCE; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SALTS;

EID: 78649345798     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.08.030     Document Type: Article

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