Assessment of chemical modifications of sites in the CDRs of recombinant antibodies: Susceptibility vs. functionality of critical quality attributes

mAbs

Volumn 6, Issue 2, 2014, Pages 327-339

  Haberger, Markus ^a   Bomans, Katrin ^a   Diepold, Katharina ^a   Hook, Michaela ^a   Gassner, Jana ^a   Schlothauer, Tilman ^a   Zwick, Adrian ^a   Spick, Christian ^a   Kepert, Jochen Felix ^a   Hienz, Brigitte ^a   Wiedmann, Michael ^a   Beck, Hermann ^b   Metzger, Philipp ^b   Mølhøj, Michael ^a   Knoblich, Constanze ^b   Grauschopf, Ulla ^b   Reusch, Dietmar ^a   Bulau, Patrick ^a  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Critical quality attributes; Deamidation; Developability; Glycation; Mass spectrometry; Oxidation; Protein degradation; Quality by design; Recombinant antibodies

Indexed keywords

AMINO ACID; GLUCOSE; IMMUNOGLOBULIN G1 ANTIBODY; RECOMBINANT ANTIBODY;

ARTICLE; CHEMICAL MODIFICATION; COMPLEMENTARY DETERMINING REGION; DEAMINATION; DEGRADATION; GLYCATION; ION EXCHANGE CHROMATOGRAPHY; ISOMERIZATION; OXIDATION; PROTEIN DEGRADATION; SURFACE PLASMON RESONANCE; TEMPERATURE STRESS;

CRITICAL QUALITY ATTRIBUTES; DEAMIDATION; DEVELOPABILITY; GLYCATION; MASS SPECTROMETRY; OXIDATION; PROTEIN DEGRADATION; QUALITY BY DESIGN; RECOMBINANT ANTIBODIES;

CHROMATOGRAPHY, ION EXCHANGE; CHROMATOGRAPHY, LIQUID; COMPLEMENTARITY DETERMINING REGIONS; GLYCOSYLATION END PRODUCTS, ADVANCED; HOT TEMPERATURE; HUMANS; HYDROGEN-ION CONCENTRATION; IMMUNOGLOBULIN G; MASS SPECTROMETRY; OXIDATIVE STRESS; PEPTIDE MAPPING; PROTEIN PROCESSING, POST-TRANSLATIONAL; PROTEOLYSIS; RECOMBINANT PROTEINS; SURFACE PLASMON RESONANCE;

EID: 84896514767     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.27876     Document Type: Article

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