The role of the quality assessment in the determination of overall biosimilarity: A simulated case study exercise-Reference-Cited by-同舟云学术

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The role of the quality assessment in the determination of overall biosimilarity: A simulated case study exercise

Published:2014-03 Issue:2 Volume:42 Page:128-132
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Schiestl Martin,Li Jing,Abas Arpah,Vallin Antonio,Millband Jennifer,Gao Kai,Joung Jeewon,Pluschkell Stefanie,Go Thomas,Kang Hye-Na

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference10 articles.

1. Guidelines on evaluation of similar biotherapeutic products (SBPs);WHO,2009

2. Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action;Jefferis;Trends Pharmacol Sci,2009

3. Lack of fucose on human IgG1 N-linked oligosaccharides improves binding to human Fcgamma RIII and antibody-dependent cytotoxicity;Shields;J Biol Chem,2002

4. IgG subclass-independent improvement of antibody-dependent cellular cytotoxicity by fucose removal from Asn297-linked oligosaccharides;Niwa;J Immunol Methods,2005

5. HILIC analysis of fluorescence-labeled N-glycans from recombinant biopharmaceuticals;Melmer;Anal Bioanal Chem,2010

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