Acceptable changes in quality attributes of glycosylated biopharmaceuticals.

作者: Martin Schiestl , Thomas Stangler , Claudia Torella , Tadej Čepeljnik , Hansjörg Toll

DOI: 10.1038/NBT.1839

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参考文章(10)
Arthur J Chirino, Anthony Mire-Sluis, Characterizing biological products and assessing comparability following manufacturing changes Nature Biotechnology. ,vol. 22, pp. 1383- 1391 ,(2004) , 10.1038/NBT1030
Martin J. Glennie, Ruth R. French, Mark S. Cragg, Ronald P. Taylor, Mechanisms of killing by anti-CD20 monoclonal antibodies. Molecular Immunology. ,vol. 44, pp. 3823- 3837 ,(2007) , 10.1016/J.MOLIMM.2007.06.151
Daniel Tracey, Lars Klareskog, Eric H. Sasso, Jochen G. Salfeld, Paul P. Tak, Tumor necrosis factor antagonist mechanisms of action: A comprehensive review Pharmacology & Therapeutics. ,vol. 117, pp. 244- 279 ,(2008) , 10.1016/J.PHARMTHERA.2007.10.001
Lina Reslan, Stéphane Dalle, Charles Dumontet, Understanding and circumventing resistance to anticancer monoclonal antibodies mAbs. ,vol. 1, pp. 222- 229 ,(2009) , 10.4161/MABS.1.3.8292
Joan C. Egrie, Jeffrey K. Browne, Development and characterization of novel erythropoiesis stimulating protein (NESP) Nephrology Dialysis Transplantation. ,vol. 16, pp. 3- 13 ,(2001) , 10.1093/NDT/16.SUPPL_3.3
Robert L. Shields, Jadine Lai, Rodney Keck, Lori Y. O'Connell, Kyu Hong, Y. Gloria Meng, Stefanie H. A. Weikert, Leonard G. Presta, Lack of Fucose on Human IgG1 N-Linked Oligosaccharide Improves Binding to Human FcγRIII and Antibody-dependent Cellular Toxicity Journal of Biological Chemistry. ,vol. 277, pp. 26733- 26740 ,(2002) , 10.1074/JBC.M202069200
Lawrence W. Dick, Catherine Kim, Difei Qiu, Kuang-Chuan Cheng, Determination of the origin of the N-terminal pyro-glutamate variation in monoclonal antibodies using model peptides. Biotechnology and Bioengineering. ,vol. 97, pp. 544- 553 ,(2007) , 10.1002/BIT.21260
Bernhard Antes, Sabine Amon, Andreas Rizzi, Susi Wiederkum, Manuela Kainer, Oliver Szolar, Markus Fido, Ralf Kircheis, Andreas Nechansky, Analysis of lysine clipping of a humanized Lewis-Y specific IgG antibody and its relation to Fc-mediated effector function. Journal of Chromatography B. ,vol. 852, pp. 250- 256 ,(2007) , 10.1016/J.JCHROMB.2007.01.024
Joan C Egrie, Erik Dwyer, Jeffrey K Browne, Anna Hitz, Michele A Lykos, Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin Experimental Hematology. ,vol. 31, pp. 290- 299 ,(2003) , 10.1016/S0301-472X(03)00006-7
J C Egrie, J K Browne, Development and characterization of novel erythropoiesis stimulating protein (NESP) British Journal of Cancer. ,vol. 84, pp. 3- 10 ,(2001) , 10.1054/BJOC.2001.1746