State-of-the-art and emerging trends in analytical approaches to pharmaceutical-product commercialization von Blue, Laura E, Guan, Xiaoyan, Joubert, Marisa K, Kuhns, Scott T, Moore, Stephanie, Semin, David J, Wikström, Mats, Wypych, Jette, Goudar, Chetan T

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Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product von Cantin, Greg, Liu, Qian, Shah, Bhavana, Kuhns, Scott, Wikström, Mats, Cao, Shawn, Liu, Jennifer

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Non-targeted characterization of attributes affecting antibody-FcγRIIIa V158 (CD16a) binding via online affinity chromatography-mass spectrometry von Woodall, Daniel W, Dillon, Thomas M, Kalenian, Kevin, Padaki, Rupa, Kuhns, Scott, Semin, David J, Bondarenko, Pavel V

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Investigation of a failed DNA assay leads to identification of an unexpected contaminant in a commonly used chromatography buffer von Kuhns, Scott T., Semin, David J., Soice, Neil P., Kappes, Andy, Wong, H. Edward, Hwang, Tsang‐Lin, Soto, Robert J., Csordas, Andrew T., Wu, Alexander, Martinez‐Cano, Diandra, Babayan, Melin, Pelayo, Yesenia, Hammond, Matthew R., Nashed‐Samuel, Yasser, Goudar, Chetan T.

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Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product von Seo, Neungseon, Kuhns, Scott, Andrews, Dina A., Colbert, Alexander, Chow, Vincent, Liu, Jennifer

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Fc glycan sialylation of biotherapeutic monoclonal antibodies has limited impact on antibody‐dependent cellular cytotoxicity von Branstetter, Elaine, Duff, Robert J., Kuhns, Scott, Padaki, Rupa

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Strategies to evaluate potential effector function of glycan variants: A case study of ordesekimab (AMG 714 or PRV-015) von Wei, Yu-Ling, Wegesser, Teresa, Kuhns, Scott, Werner, Jonathan, Lebrec, Hervé, Wang, Xiaoting

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Immune Complex Formation Is Associated With Loss of Tolerance and an Antibody Response to Both Drug and Target von Kroenke, Mark A, Barger, Troy E, Hu, Jenny, Miller, Mieke Jill, Kalenian, Kevin, He, Lidong, Hsu, Hailing, Bartley, Yessenia, Chow, Vincent Fung-Sing, Teixeira Dos Santos, Marcia Cristina, Sullivan, Barbara A, Cheng, Laurence E, Parnes, Jane R, Padaki, Rupa, Kuhns, Scott, Mytych, Daniel T

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Engineering protein glycosylation in CHO cells to be highly similar to murine host cells von Gupta, Shivani, Shah, Bhavana, Fung, Coral Shek, Chan, Pik Kay, Wakefield, Devin L, Kuhns, Scott, Goudar, Chetan T, Piret, James M

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Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product von Seo, Neungseon, Guan, Xiaoyan, Wang, Tian, Chung, Hyo S. Helen, Wikström, Mats, Padaki, Rupa, Kalenian, Kevin, Kuhns, Scott, Matthies, Kelli, Crouse-Zeineddini, Jill, Wong, Helen Y., Ng, Michael, Foltz, Ian N., Cao, Shawn, Liu, Jennifer

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Accuracy and sensitivity of residual DNA detection by QPCR is not predicted by target copy number von Verardo, Megan L., Carvalho, Juliane G., Delgado, Dora N., Kuhns, Scott T.

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Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab von Liu, Jennifer, Eris, Tamer, Li, Cynthia, Cao, Shawn, Kuhns, Scott

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Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab von Seo, Neungseon, Polozova, Alla, Zhang, Mingxuan, Yates, Zachary, Cao, Shawn, Li, Huimin, Kuhns, Scott, Maher, Gwendolyn, McBride, Helen J, Liu, Jennifer

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Functional Similarity of Proposed Biosimilar ABP 798 with Rituximab von McBride, Helen, Maher, Gwendolyn, Sweet, Heather, Foltz, Ian, Kuhns, Scott

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Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product von Saleem, Ramsey, Cantin, Greg, Wikström, Mats, Bolton, Glen, Kuhns, Scott, McBride, Helen J., Liu, Jennifer

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Mo1733 - ABP 501: Matching the Critical Functions of Adalimumab von McBride, Helen, Kuhns, Scott, Foltz, Ian, Sweet, Heather, Kaur, Primal

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ABP 501: Matching the Critical Functions of Adalimumab von McBride, Helen, Kuhns, Scott, Foltz, Ian, Sweet, Heather, Kaur, Primal

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Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product von Seo, Neungseon, Huang, Zhe, Kuhns, Scott, Sweet, Heather, Cao, Shawn, Wikström, Mats, Liu, Jennifer

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Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab von Hutterer, Katariina M., Polozova, Alla, Kuhns, Scott, McBride, Helen J., Cao, Xingxiang, Liu, Jennifer

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Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product von Hutterer, Katariina M., Ip, Anna, Kuhns, Scott, Cao, Shawn, Wikström, Mats, Liu, Jennifer

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