How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations.
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Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational ModificationsAssessing the Immunogenicity of BiopharmaceuticalsDangerous liaisons: how the immune system deals with factor VIIIClinical considerations for biosimilar antibodies.Strategies to compare clinical antitherapeutic antibody data when changing assay platforms: a case study.Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.Implications of the presence of N-glycolylneuraminic acid in recombinant therapeutic glycoproteins.At least two Fc Neu5Gc residues of monoclonal antibodies are required for binding to anti-Neu5Gc antibodyImmunogenicity of therapeutic recombinant immunotoxins.Transduction of human recombinant proteins into mitochondria as a protein therapeutic approach for mitochondrial disorders.Protein particulate detection issues in biotherapeutics development--current status.The effect of neutralizing antibodies on the sustainable efficacy of biologic therapies: what's in it for African and Middle Eastern rheumatologists.Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation.The advent of biosimilars for the treatment of diabetes: current status and future directions.From the bench to clinical practice: understanding the challenges and uncertainties in immunogenicity testing for biopharmaceuticals.Physical characterization and in vitro biological impact of highly aggregated antibodies separated into size-enriched populations by fluorescence-activated cell sorting.The immunogenicity of antibody aggregates in a novel transgenic mouse model.European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK14-day repeat-dose oral toxicity evaluation of oxazyme in rats and dogs.The Immunogenicity of Branded and Biosimilar Infliximab in Rheumatoid Arthritis According to Th9-Related Responses.Host cell proteins in biotechnology-derived products: A risk assessment framework.Immunosafety of recombinant human C1-inhibitor in hereditary angioedema: evaluation of ige antibodies.Immunogenicity assessment of recombinant human c1-inhibitor: an integrated analysis of clinical studies.Safety of biologics in psoriasis.Progress and Challenges in the Design and Clinical Development of Antibodies for Cancer Therapy.Secukinumab Demonstrates Significantly Lower Immunogenicity Potential Compared to Ixekizumab.
P2860
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P2860
How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations.
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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 05 April 2009
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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
How to systematically evaluate ...... s - regulatory considerations.
@en
How to systematically evaluate ...... s - regulatory considerations.
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type
label
How to systematically evaluate ...... s - regulatory considerations.
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How to systematically evaluate ...... s - regulatory considerations.
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prefLabel
How to systematically evaluate ...... s - regulatory considerations.
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How to systematically evaluate ...... s - regulatory considerations.
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P1433
P1476
How to systematically evaluate ...... s - regulatory considerations.
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P2093
Christian K Schneider
Eva-Maria Jahn
P304
P356
10.1016/J.NBT.2009.03.012
P577
2009-04-05T00:00:00Z