Liquid chromatography coupled with tandem mass spectrometry for the bioanalysis of proteins in drug development: Practical considerations in assay development and validation

Journal of Chromatography A

Volumn 1284, Issue , 2013, Pages 155-162

  Liu, Guowen ^a   Ji, Qin C ^a   Dodge, Robert ^a   Sun, Huadong ^a   Shuster, David ^a   Zhao, Qihong ^a   Arnold, Mark ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Biotherapeutics; LC MS MS; Monoclonal antibody; Validation

Indexed keywords

BIOLOGICAL MATRIXES; BIOTHERAPEUTICS; LC-MS/MS; LIQUID CHROMATOGRAPHY COUPLED WITH TANDEM MASS SPECTROMETRIES; OPERATIONAL ASPECTS; REGULATED BIOANALYSIS; SAMPLE PREPARATION; VALIDATION;

ASSAYS; DRUG PRODUCTS; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MONOCLONAL ANTIBODIES;

PROTEINS;

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY MABX; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; CONTROLLED STUDY; LIGAND BINDING; LIQUID CHROMATOGRAPHY; MOUSE; NONHUMAN; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROTEIN ANALYSIS; QUANTITATIVE ANALYSIS; RELIABILITY; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

ANIMALS; ANTIBODIES, MONOCLONAL; CALIBRATION; CHROMATOGRAPHY, LIQUID; DRUG DISCOVERY; MICE; PEPTIDE FRAGMENTS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; TANDEM MASS SPECTROMETRY; TRYPSIN;

EID: 84874979476     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2013.02.016     Document Type: Article

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