Enhanced monitoring of biopharmaceutical product purity using liquid chromatography-mass spectrometry

Journal of Chromatography A

Volumn 1218, Issue 28, 2011, Pages 4340-4348

  Laursen, Kristoffer ^a,b   Justesen, Ulla ^b   Rasmussen, Morten A ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b NOVO NORDISK A S   (Denmark)

Author keywords

Impurity detection; LC MS; Multiple testing; Multivariate statistical process control (MSPC); Principal component analysis (PCA); Signal preprocessing

Indexed keywords

LC-MS; MULTIPLE TESTING; MULTIVARIATE STATISTICAL PROCESS CONTROL; PRINCIPAL COMPONENT ANALYSIS (PCA); SIGNAL PREPROCESSING;

IMPURITIES; LIQUIDS; MASS SPECTROMETRY; MULTIVARIANT ANALYSIS; PRINCIPAL COMPONENT ANALYSIS; QUALITY CONTROL; STATISTICAL PROCESS CONTROL;

LIQUID CHROMATOGRAPHY;

DESB30 INSULIN; INSULIN DERIVATIVE; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; AUTOMATION; CONTROLLED STUDY; DRUG IMPURITY; DRUG PURITY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS;

CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, LIQUID; HUMANS; INSULIN; MASS SPECTROMETRY; MULTIVARIATE ANALYSIS; PHARMACEUTICAL PREPARATIONS; PRINCIPAL COMPONENT ANALYSIS; RECOMBINANT PROTEINS; SIGNAL PROCESSING, COMPUTER-ASSISTED;

EID: 79959351051     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2011.04.080     Document Type: Article

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