Acceptable changes in quality attributes of glycosylated biopharmaceuticals
about
Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseasesGlycotherapy: new advances inspire a reemergence of glycans in medicineExperience with biosimilar infliximab (CT-P13) in paediatric patients with inflammatory bowel diseasesWaiving in vivo studies for monoclonal antibody biosimilar development: National and global challengesBiosimilar: what it is notGlycan analysis of therapeutic glycoproteinsIn vitro glycoengineering of IgG1 and its effect on Fc receptor binding and ADCC activityAnalytical techniques and bioactivity assays to compare the structure and function of filgrastim (granulocyte-colony stimulating factor) therapeutics from different manufacturers.Clinical considerations for biosimilar antibodies.Consistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab).The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?High-throughput biophysical analysis and data visualization of conformational stability of an IgG1 monoclonal antibody after deglycosylation.Biosimilars: Implications for health-system pharmacists.PCR on yeast colonies: an improved method for glyco-engineered Saccharomyces cerevisiae.Etanercept biosimilarsGlycosylation profiles determine extravasation and disease-targeting properties of armed antibodiesAdvanced mass spectrometry workflows for analyzing disulfide bonds in biologics.Biosimilars: a systematic review of published and ongoing clinical trials of antipsoriatics in chronic inflammatory diseases.Emerging technologies for making glycan-defined glycoproteinsThe economic pressures for biosimilar drug use in cancer medicineComparison of Fc N-Glycosylation of Pharmaceutical Products of Intravenous Immunoglobulin GBiosimilar granulocyte-colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?Tolerability, pharmacokinetics and pharmacodynamics of CMAB007, a humanized anti-immunoglobulin E monoclonal antibody, in healthy Chinese subjects.7th annual European Antibody Congress 2011: November 29-December 1, 2011, Geneva, Switzerland.Current status and future prospects for biologic treatments of psoriasis.Chemoenzymatic glycoengineering of intact IgG antibodies for gain of functions.Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance CentersCharacterization and comparison of commercially available TNF receptor 2-Fc fusion protein productsTraceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports.A novel approach for the simultaneous quantification of a therapeutic monoclonal antibody in serum produced from two distinct host cell lines.Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: a population-based cohort study in Italy.Biosimilar recombinant human erythropoietins ("epoetins") and future erythropoiesis-stimulating treatments.Transgenesis applied to goat: current applications and ongoing research.Rituximab biosimilars.Proposal for a new nomenclature of disease-modifying antirheumatic drugs.Drift, evolution, and divergence in biologics and biosimilars manufacturing.Future directions in inflammatory bowel disease management.The ESA scenario gets complex: from biosimilar epoetins to activin traps.Barriers to the uptake of biosimilars and possible solutions: a Belgian case study.
P2860
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P2860
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
description
2011 nî lūn-bûn
@nan
2011 թուականի Ապրիլին հրատարակուած գիտական յօդուած
@hyw
2011 թվականի ապրիլին հրատարակված գիտական հոդված
@hy
2011年の論文
@ja
2011年論文
@yue
2011年論文
@zh-hant
2011年論文
@zh-hk
2011年論文
@zh-mo
2011年論文
@zh-tw
2011年论文
@wuu
name
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@ast
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@en
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@nl
type
label
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@ast
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@en
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@nl
prefLabel
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@ast
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@en
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@nl
P2093
P2860
P3181
P356
P1433
P1476
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
@en
P2093
Claudia Torella
Hansjörg Toll
Martin Schiestl
Roger Grau
Tadej Cepeljnik
Thomas Stangler
P2860
P2888
P3181
P356
10.1038/NBT.1839
P407
P577
2011-04-01T00:00:00Z
P6179
1027451900