Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics

mAbs

Volumn 7, Issue 5, 2015, Pages 881-890

  Rogers, Richard S ^a,b   Nightlinger, Nancy S ^a   Livingston, Brittney ^a,b   Campbell, Phil ^a   Bailey, Robert ^a,c   Balland, Alain ^a,d  

^a AMGEN INC   (United States)

^b Just Biotherapeutics   (United States)

^c Zymeworks Inc   (United States)

^d BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Monoclonal antibody; Multi attribute method (MAM); Peptide map; Product quality attributes; Quality by design

Indexed keywords

BIOLOGICAL PRODUCT; GLYCAN; IMMUNOGLOBULIN G2A ANTIBODY; STREPTAVIDIN; TRYPSIN; MONOCLONAL ANTIBODY;

ALKYLATION; AMINO ACID SEQUENCE; ARTICLE; CAPILLARY ELECTROPHORESIS; DEAMINATION; DRUG DISPOSITION; HEAVY CHAIN; HYDROPHILIC INTERACTION CHROMATOGRAPHY; ION EXCHANGE CHROMATOGRAPHY; LIGHT CHAIN; MASS SPECTROMETRY; MEASUREMENT PRECISION; MEASUREMENT REPEATABILITY; MULTI ATTRIBUTE METHOD; OXIDATION; PEPTIDE MAPPING; PROTEIN DEGRADATION; PROTEIN PROCESSING; QUALITY CONTROL; REDUCTION; REVERSED PHASE LIQUID CHROMATOGRAPHY; SYSTEM ANALYSIS; AFFINITY CHROMATOGRAPHY; CHEMISTRY; LIQUID CHROMATOGRAPHY; MOLECULAR GENETICS; PHARMACEUTICS; PROCEDURES; SOFTWARE; STANDARDS;

AMINO ACID SEQUENCE; ANTIBODIES, MONOCLONAL; BIOLOGICAL PRODUCTS; CHROMATOGRAPHY, AFFINITY; CHROMATOGRAPHY, LIQUID; MASS SPECTROMETRY; MOLECULAR SEQUENCE DATA; PEPTIDE MAPPING; PROTEIN PROCESSING, POST-TRANSLATIONAL; QUALITY CONTROL; SOFTWARE; TECHNOLOGY, PHARMACEUTICAL;

EID: 84953395541     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2015.1069454     Document Type: Article

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