Quantitative impurity analysis of monoclonal antibody size heterogeneity by CE-LIF: Example of development and validation through a quality-by-design framework

Electrophoresis

Volumn 33, Issue 5, 2012, Pages 815-826

  Michels, David A ^a   Parker, Monica ^a   Salas Solano, Oscar ^b  

^a GENENTECH INC   (United States)

^b SEATTLE GENETICS INC   (United States)

Author keywords

CE SDS; Design of experiment; Monoclonal antibody; Quality by design; Validation

Indexed keywords

CAPILLARY ELECTROPHORESIS; CONTROLLED DRUG DELIVERY; CYANIDES; DRUG PRODUCTS; IMPURITIES; MONOCLONAL ANTIBODIES; PRODUCT DESIGN; QUALITY CONTROL; ROBUSTNESS (CONTROL SYSTEMS); SODIUM DODECYL SULFATE; SULFUR COMPOUNDS;

CAPILLARY ELECTROPHORESIS-SODIUM DODECYL SULPHATE; DESIGN FRAMEWORKS; DRUG EFFICACY; IMPURITY ANALYSIS; LABELINGS; OPTIMISATIONS; PATIENT SAFETY; QUALITY BY DESIGNS; SODIUM DODECYL SULPHATE; VALIDATION;

DESIGN OF EXPERIMENTS;

MONOCLONAL ANTIBODY;

ANALYTIC METHOD; ARTICLE; ARTIFACT REDUCTION; CAPILLARY ELECTROPHORESIS; CONTROL STRATEGY; CONTROLLED STUDY; DRUG IMPURITY; FLUORESCENCE ANALYSIS; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MOLECULAR WEIGHT; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; QUANTITATIVE ANALYSIS; THERMOREGULATION; VALIDATION STUDY;

EID: 84860259177     PISSN: 01730835     EISSN: 15222683     Source Type: Journal    
DOI: 10.1002/elps.201100528     Document Type: Article

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