Classification and Characterization of Therapeutic Antibody Aggregates von Joubert, Marisa K., Luo, Quanzhou, Nashed-Samuel, Yasser, Wypych, Jette, Narhi, Linda O.

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Chemical Modifications in Therapeutic Protein Aggregates Generated under Different Stress Conditions von Luo, Quanzhou, Joubert, Marisa K., Stevenson, Riki, Ketchem, Randal R., Narhi, Linda O., Wypych, Jette

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Direct mass spectrometric characterization of disulfide linkages von Guan, Xiaoyan, Zhang, Le, Wypych, Jette

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Structural and Functional Characterization of Disulfide Isoforms of the Human IgG2 Subclass von Dillon, Thomas M., Ricci, Margaret Speed, Vezina, Chris, Flynn, Gregory C., Liu, Yaoqing Diana, Rehder, Douglas S., Plant, Matthew, Henkle, Brad, Li, Yu, Deechongkit, Songpon, Varnum, Brian, Wypych, Jette, Balland, Alain, Bondarenko, Pavel V.

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Human IgG2 Antibodies Display Disulfide-mediated Structural Isoforms von Wypych, Jette, Li, Ming, Guo, Amy, Zhang, Zhongqi, Martinez, Theresa, Allen, Martin J., Fodor, Szilan, Kelner, Drew N., Flynn, Gregory C., Liu, Yaoqing Diana, Bondarenko, Pavel V., Ricci, Margaret Speed, Dillon, Thomas M., Balland, Alain

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Development of a Human Antibody Tolerant Mouse Model to Assess the Immunogenicity Risk Due to Aggregated Biotherapeutics von Bi, Vivian, Jawa, Vibha, Joubert, Marisa K., Kaliyaperumal, Arunan, Eakin, Catherine, Richmond, Karen, Pan, Oscar, Sun, Jilin, Hokom, Martha, Goletz, Theresa J., Wypych, Jette, Zhou, Lei, Kerwin, Bruce A., Narhi, Linda O., Arora, Taruna

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In Vitro Stoichiometry of Complexes between the Soluble RANK Ligand and the Monoclonal Antibody Denosumab von Arthur, Kelly K, Gabrielson, John P, Hawkins, Nessa, Anafi, Dan, Wypych, Jette, Nagi, Athena, Sullivan, John K, Bondarenko, Pavel V

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Observation of Heavy-Chain C-Terminal Des-GK Truncation in Recombinant and Human Endogenous IgG4 von Shah, Bhavana, Zhu, YaXing, Wypych, Jette, Zhang, Zhongqi

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Observation of Heavy-Chain C-Terminal Amidation in Human Endogenous IgG von Shah, Bhavana, Li, Ming, Wypych, Jette, Joubert, Marisa K., Zhang, Zhongqi

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Analytical Quality by Design, Life Cycle Management, and Method Control von Verch, Thorsten, Campa, Cristiana, Chéry, Cyrille C., Frenkel, Ruth, Graul, Timothy, Jaya, Nomalie, Nakhle, Bassam, Springall, Jeremy, Starkey, Jason, Wypych, Jette, Ranheim, Todd

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Structural Characterization of a Monoclonal Antibody–Maytansinoid Immunoconjugate von Luo, Quanzhou, Chung, Hyo Helen, Borths, Christopher, Janson, Matthew, Wen, Jie, Joubert, Marisa K, Wypych, Jette

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A Mass Spectrometric Characterization of Light-Induced Modifications in Therapeutic Proteins von Zhang, Zhongqi, Chow, Sih-Yao, De Guzman, Ronandro, Joh, Nathan H., Joubert, Marisa K., Richardson, Jason, Shah, Bhavana, Wikström, Mats, Zhou, Zhaohui Sunny, Wypych, Jette

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Capillary Zone Electrophoresis Method for a Highly Glycosylated and Sialylated Recombinant Protein: Development, Characterization and Application for Process Development von Zhang, Le, Lawson, Ken, Yeung, Bernice, Wypych, Jette

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Observation and Mitigation of Leachables from Non-Product Contact Materials in Electromechanical Delivery Devices for Biotechnology Products von Liu, Jian, Ronk, Michael, Luo, Yanxin, Wypych, Jette, Zhang, Zhongqi, Perez-Pacheco, Joel, Jin, Ellen, Shah, Bhavana, Richardson, Jason, Li, Kim, Semin, David, Nashed-Samuel, Yasser

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Improved sequence variant analysis strategy by automated false positive removal von Li, Wenzhou, Wypych, Jette, Duff, Robert J

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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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Engineering an IgG Scaffold Lacking Effector Function with Optimized Developability von Jacobsen, Frederick W., Stevenson, Riki, Li, Cynthia, Salimi-Moosavi, Hossein, Liu, Ling, Wen, Jie, Luo, Quanzhou, Daris, Kristine, Buck, Lynette, Miller, Sterling, Ho, Shu-Yin, Wang, Wei, Chen, Qing, Walker, Kenneth, Wypych, Jette, Narhi, Linda, Gunasekaran, Kannan

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A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic von Cohen, Joseph R., Brych, Stephen R., Prabhu, Siddharth, Bi, Vivian, Elbaradei, Ahmed, Tokuda, Joshua M., Xiang, Cathie, Hokom, Martha, Cui, Xiaohong, Ly, Claudia, Amos, Nathan, Sun, Jilin, Calamba, Dominador, Herskovitz, Jonathan, Capili, Allyson, Nourbakhsh, Kimya, Merlo, Anthony, Carreon, Julia, Wypych, Jette, Narhi, Linda O., Jawa, Vibha, Joubert, Marisa K.

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Observation and Mitigation of Lamellar Silica Particles Formed in Pharmaceutical Products Packaged in Glass Vials von Nashed-Samuel, Yasser, Gastwirt, Jeremy, Kotia, Ruchi B, Moore, Stephanie, Masatani, Peter, Torraca, Gianpiero, Goss, Monica, Dolan, David G, Akers, Michael, Padala, Chakradhar, Wypych, Jette, Semin, David J

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A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy von Rogers, Richard S., Abernathy, Michael, Richardson, Douglas D., Rouse, Jason C., Sperry, Justin B., Swann, Patrick, Wypych, Jette, Yu, Christopher, Zang, Li, Deshpande, Rohini

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