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Een shown to be similar to adalimumab with respect to binding to a panel of Fc receptors, including FccRIa, FccRIIa, FccRIIIa (158V) (with and without TNFa), and FccRIIIa (158F). Importantly, effector function activation (ADCC and CDC) was also demonstrated to be similar between ABP 501 and adalimumab using highly sensitive methods. The ADCC and CDC methods have been demonstrated to be sensitive t
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Een shown to be similar to adalimumab with respect to binding to a panel of Fc receptors, including FccRIa, FccRIIa, FccRIIIa (158V) (with and without TNFa), and FccRIIIa (158F). Importantly, effector function activation (ADCC and CDC) was also demonstrated to be similar between ABP 501 and adalimumab using highly sensitive methods. The ADCC and CDC methods have been demonstrated to be sensitive t
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Rmer employees and stockholders of Amgen, Inc. Yuh-feng Chen, Gwen Maher, and Teresa L. Born are employees and stockholders of Amgen, Inc. Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medi
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Rmer employees and stockholders of Amgen, Inc. Yuh-feng Chen, Gwen Maher, and Teresa L. Born are employees and stockholders of Amgen, Inc. Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medi
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Alimumab (US) (black), and adalimumab (EU) (blue). Each point represents results from testing a unique lot. The dotted lines represent the quality range established based on the adalimumab (US) lots tested (mean ?3 standard deviations). Adalimumab (EU) EU-authorized adalimumab, adalimumab (US) FDA-licensed adalimumab, CDC complementdependent cytotoxicityFunctional Characterization of ABP 501, Bios
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Rmer employees and stockholders of Amgen, Inc. Yuh-feng Chen, Gwen Maher, and Teresa L. Born are employees and stockholders of Amgen, Inc. Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medi
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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 re