Quantitation and characterization of process impurities and extractables in protein-containing solutions using proton NMR as a general tool

Biotechnology Progress

Volumn 28, Issue 6, 2012, Pages 1526-1533

  Skidmore, Ken ^a   Hewitt, Daniel ^a   Kao, Yung Hsiang ^a  

^a GENENTECH INC   (United States)

Author keywords

CPMG; Impurities; Leachables; NMR spectroscopy; Process validation

Indexed keywords

BIOPHARMACEUTICAL PRODUCTS; CPMG; EXTRACTABLES; GENERAL TOOLS; HIGH MOLECULAR WEIGHT; IMPURITIES IN; LEACHABLES; LOW LEVEL; MANUFACTURING PROCESS; NMR SPECTRUM; PROCESS VALIDATION; PROTON NMR; PULSE SEQUENCE; RIGOROUS VALIDATION; SMALL MOLECULES;

IMPURITIES; MOLECULAR WEIGHT; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY;

PROTEINS;

MONOCLONAL ANTIBODY; PROTEIN;

ARTICLE; CHEMISTRY; DRUG CONTAMINATION; METHODOLOGY; NUCLEAR MAGNETIC RESONANCE; PHARMACEUTICS; REPRODUCIBILITY; STATISTICAL MODEL;

ANTIBODIES, MONOCLONAL; DRUG CONTAMINATION; LINEAR MODELS; NUCLEAR MAGNETIC RESONANCE, BIOMOLECULAR; PROTEINS; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84872404816     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1620     Document Type: Article

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