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Le lots) and biofunctional parameters. The biofunctional parameters tested include an assessment of both binding and function within both the Fab and Fc portions of the mAb.Acknowledgments The authors thank Abhishek Mathur for scientific and technical contributions to the reported data and Jennifer Liu, Jill Crouse-Zeineddini, and Scott Kuhns for guidance on overall similarity assessment strategy
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Mith, T. 1987. Eukaryotes with no mitochondria. Nature 326: 332?33. 30. Cavalier-Smith, T. 1987. The origin of eukaryotic and archaebacterial cells. Ann. N. Y. Acad. Sci. 503:17?4. 30a.Cavalier-Smith, T. 1991. The evolution of cells, p. 271?04. In S. Osawa and T. Honjo (ed.), Evolution of life. Springer-Verlag, Tokyo, Japan. 31. Cavalier-Smith, T. 1992. Origins of secondary metabolism. Ciba Found
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Function testing. Teresa L. Born is the corresponding author and is responsible for the overall design and execution of the studies. Yuh-feng Chen is the subject expert for potency assessment and he contributed to the authoring and reviewing of this manuscript. Amanda Rohrbach, Christina Pastula, and Gwen Maher are the subject experts for binding assays and they contributed to the authoring and r

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Certolizumab is reduced in Crohn's disease relative to the efficacy observed with adalimumab [24, 25], which suggests that Fc-mediated effector functions may be important. Binding of mAbs to FcRn affects clearance, so a similarity assessment of biosimilars should also include sensitive methods to assess binding to FcRn. ABP 501 was shown to have similar binding to FcRn as compared with adalimumab
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