Assessing monoclonal antibody product quality attribute criticality through clinical studies.
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Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational ModificationsAdvances in recombinant antibody manufacturingHigh-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans.Engineered Bispecific Antibodies with Exquisite HIV-1-Neutralizing Activity.Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques.A novel approach for the simultaneous quantification of a therapeutic monoclonal antibody in serum produced from two distinct host cell lines.IgG1 thioether bond formation in vivo.Rapid quantitative analysis of monoclonal antibody heavy and light chain charge heterogeneityAnalytical methods for physicochemical characterization of antibody drug conjugatesQuality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach.Post-translational structural modifications of immunoglobulin G and their effect on biological activity.Assessment of chemical modifications of sites in the CDRs of recombinant antibodies: Susceptibility vs. functionality of critical quality attributes.Microheterogeneity of therapeutic monoclonal antibodies is governed by changes in the surface charge of the protein.Forced degradation studies: current trends and future perspectives for protein-based therapeutics.Assessment of disulfide and hinge modifications in monoclonal antibodiesCharge heterogeneity: Basic antibody charge variants with increased binding to Fc receptors.Quantitation and pharmacokinetic modeling of therapeutic antibody quality attributes in human studies.Marketing approval of mogamulizumab: a triumph for glyco-engineering.Assessing in vivo dynamics of multiple quality attributes from a therapeutic IgG4 monoclonal antibody circulating in cynomolgus monkeyC-terminal lysine processing of human immunoglobulin G2 heavy chain in vivo.High-Throughput Process Development for Biopharmaceuticals.Microheterogeneity of Recombinant Antibodies: Analytics and Functional Impact.Evaluation of fluorescent dyes to measure protein aggregation within mammalian cell culture supernatants.Assessment of susceptible chemical modification sites of trastuzumab and endogenous human immunoglobulins at physiological conditions
P2860
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P2860
Assessing monoclonal antibody product quality attribute criticality through clinical studies.
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article científic
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article scientifique
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articolo scientifico
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artigo científico
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bilimsel makale
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scientific article published on September 2010
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vedecký článok
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vetenskaplig artikel
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videnskabelig artikel
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vědecký článek
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name
Assessing monoclonal antibody ...... lity through clinical studies.
@en
Assessing monoclonal antibody ...... lity through clinical studies.
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type
label
Assessing monoclonal antibody ...... lity through clinical studies.
@en
Assessing monoclonal antibody ...... lity through clinical studies.
@nl
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Assessing monoclonal antibody ...... lity through clinical studies.
@en
Assessing monoclonal antibody ...... lity through clinical studies.
@nl
P2093
P2860
P356
P1476
Assessing monoclonal antibody ...... lity through clinical studies.
@en
P2093
Andrew M Goetze
Gregory C Flynn
Matthew R Schenauer
P2860
P304
P356
10.4161/MABS.2.5.12897
P577
2010-09-01T00:00:00Z