Literature DB >> 21478841

Acceptable changes in quality attributes of glycosylated biopharmaceuticals.

Martin Schiestl, Thomas Stangler, Claudia Torella, Tadej Cepeljnik, Hansjörg Toll, Roger Grau.   

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Year:  2011        PMID: 21478841     DOI: 10.1038/nbt.1839

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN: 1087-0156            Impact factor:   54.908


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  9 in total

1.  Characterizing biological products and assessing comparability following manufacturing changes.

Authors:  Arthur J Chirino; Anthony Mire-Sluis
Journal:  Nat Biotechnol       Date:  2004-11       Impact factor: 54.908

2.  Analysis of lysine clipping of a humanized Lewis-Y specific IgG antibody and its relation to Fc-mediated effector function.

Authors:  Bernhard Antes; Sabine Amon; Andreas Rizzi; Susi Wiederkum; Manuela Kainer; Oliver Szolar; Markus Fido; Ralf Kircheis; Andreas Nechansky
Journal:  J Chromatogr B Analyt Technol Biomed Life Sci       Date:  2007-01-26       Impact factor: 3.205

Review 3.  Mechanisms of killing by anti-CD20 monoclonal antibodies.

Authors:  Martin J Glennie; Ruth R French; Mark S Cragg; Ronald P Taylor
Journal:  Mol Immunol       Date:  2007-09       Impact factor: 4.407

4.  Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity.

Authors:  Robert L Shields; Jadine Lai; Rodney Keck; Lori Y O'Connell; Kyu Hong; Y Gloria Meng; Stefanie H A Weikert; Leonard G Presta
Journal:  J Biol Chem       Date:  2002-05-01       Impact factor: 5.157

5.  Determination of the origin of the N-terminal pyro-glutamate variation in monoclonal antibodies using model peptides.

Authors:  Lawrence W Dick; Catherine Kim; Difei Qiu; Kuang-Chuan Cheng
Journal:  Biotechnol Bioeng       Date:  2007-06-15       Impact factor: 4.530

Review 6.  Tumor necrosis factor antagonist mechanisms of action: a comprehensive review.

Authors:  Daniel Tracey; Lars Klareskog; Eric H Sasso; Jochen G Salfeld; Paul P Tak
Journal:  Pharmacol Ther       Date:  2007-10-26       Impact factor: 12.310

7.  Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin.

Authors:  Joan C Egrie; Erik Dwyer; Jeffrey K Browne; Anna Hitz; Michele A Lykos
Journal:  Exp Hematol       Date:  2003-04       Impact factor: 3.084

Review 8.  Understanding and circumventing resistance to anticancer monoclonal antibodies.

Authors:  Lina Reslan; Stéphane Dalle; Charles Dumontet
Journal:  MAbs       Date:  2009-05-24       Impact factor: 5.857

Review 9.  Development and characterization of novel erythropoiesis stimulating protein (NESP).

Authors:  J C Egrie; J K Browne
Journal:  Br J Cancer       Date:  2001-04       Impact factor: 7.640

  9 in total
  125 in total

Review 1.  Emerging technologies for making glycan-defined glycoproteins.

Authors:  Lai-Xi Wang; Joseph V Lomino
Journal:  ACS Chem Biol       Date:  2011-12-14       Impact factor: 5.100

2.  Tolerability, pharmacokinetics and pharmacodynamics of CMAB007, a humanized anti-immunoglobulin E monoclonal antibody, in healthy Chinese subjects.

Authors:  Bo Zhou; Birong Lin; Jing Li; Weizhu Qian; Sheng Hou; Dapeng Zhang; Geng Kou; Bohua Li; Hao Wang; Yongchuan Chen; Yajun Guo
Journal:  MAbs       Date:  2012 Jan-Feb       Impact factor: 5.857

3.  7th annual European Antibody Congress 2011: November 29-December 1, 2011, Geneva, Switzerland.

Authors:  Alexey A Lugovskoy; Janice M Reichert; Alain Beck
Journal:  MAbs       Date:  2012-03-01       Impact factor: 5.857

Review 4.  The advent of biosimilar therapies in rheumatology--"O brave new world".

Authors:  Morton A Scheinberg; Jonathan Kay
Journal:  Nat Rev Rheumatol       Date:  2012-06-05       Impact factor: 20.543

5.  [Regulatory aspects of biosimilars. Myths and facts].

Authors:  C K Schneider; M Weise
Journal:  Z Rheumatol       Date:  2015-10       Impact factor: 1.372

6.  Analytical and Biological Characterization of a Noninnovator Insulin Glargine and the Originator Drug Product.

Authors:  Abraham Escobedo-Moratilla; Francisco Kuri-Breña Romero de Terreros; José Pérez-Urizar; Ana Paulina Barba de la Rosa
Journal:  J Diabetes Sci Technol       Date:  2015-10-01

7.  [Biosimilars versus original biologics. Similarities and differences from development to approval].

Authors:  J Windisch
Journal:  Z Rheumatol       Date:  2015-10       Impact factor: 1.372

8.  Galactosylation variations in marketed therapeutic antibodies.

Authors:  T Shantha Raju; Robert E Jordan
Journal:  MAbs       Date:  2012-04-26       Impact factor: 5.857

9.  Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.

Authors:  Niels S Vermeer; Sabine M J M Straus; Aukje K Mantel-Teeuwisse; Francois Domergue; Toine C G Egberts; Hubert G M Leufkens; Marie L De Bruin
Journal:  Drug Saf       Date:  2013-08       Impact factor: 5.606

10.  Barriers to the uptake of biosimilars and possible solutions: a Belgian case study.

Authors:  Pieter Dylst; Arnold Vulto; Steven Simoens
Journal:  Pharmacoeconomics       Date:  2014-07       Impact factor: 4.981

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