未登录 Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products 评估生物制药产品中可见硅油颗粒的临床安全性和分析影响 Saggu, Miguel; Bou-Assaf, George M.; Bucher, Reinhard; Budyak, Ivan L.; Buecheler, Jakob; Cao, Shawn; Groenning, Minna; Khan, Emon; Kwok, Stanley C.; Minocha, Shalini; Pisupati, Karthik; Radhakrishnan, Vinay; Videbaek, Nicoline; Yang, Dennis T.; Zhang, Bin; Narhi, Linda O. 分享 收藏
A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic 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. 分享 收藏
Development of in silico models to predict viscosity and mouse clearance using a comprehensive analytical data set collected on 83 scaffold-consistent monoclonal antibodies 使用在83种支架一致的单克隆抗体上收集的综合分析数据集，开发计算机模型来预测粘度和小鼠清除率 Mock, Marissa; Jacobitz, Alex W.; Langmead, Christopher James; Sudom, Athena; Yoo, Daniel; Humphreys, Sara C.; Alday, Mai; Alekseychyk, Larysa; Angell, Nicolas; Bi, Vivian; Catterall, Hannah; Chen, Chen-Chun; Chou, Hui-Ting; Conner, Kip P.; Cook, Kevin D.; Correia, Ana R.; Dykstra, Andrew; Ghimire-Rijal, Sudipa; Graham, Kevin; Grandsard, Peter; Huh, Joon; Hui, John O.; Jain, Mani; Jann, Victoria; Jia, Lei; Johnstone, Sheree; Khanal, Neelam; Kolvenbach, Carl; Narhi, Linda; Padaki, Rupa; Pelegri-O'Day, Emma M.; Qi, Wei; Razinkov, Vladimir; Rice, Austin J.; Smith, Richard; Spahr, Christopher; Stevens, Jennitte; Sun, Yax; Thomas, Veena A.; van Driesche, Sarah; Vernon, Robert; Wagner, Victoria; Walker, Kenneth W.; Wei, Yangjie; Winters, Dwight; Yang, Melissa; Campuzano, Iain D. G. 分享 收藏
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Stress Factors in Primary Packaging, Transportation and Handling of Protein Drug Products and Their Impact on Product Quality Narhi, Linda O.; Chou, Danny K.; Christian, Twinkle R.; Gibson, Scott; Jagannathan, Bharat; Jiskoot, Wim; Jordan, Susan; Sreedhara, Alavattam; Waxman, Lloyd; Das, Tapan K. 分享 收藏
Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality Das, Tapan K.; Sreedhara, Alavattam; Colandene, James D.; Chou, Danny K.; Filipe, Vasco; Grapentin, Christoph; Searles, Jim; Christian, Twinkle R.; Narhi, Linda O.; Jiskoot, Wim 分享 收藏
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Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems Joh, Nathan H.; Thomas, Lisa; Christian, Twinkle R.; Verlinsky, Alla; Jiao, Nancy; Allotta, Nilo; Jawa, Vibha; Cao, Shawn; Narhi, Linda O.; Joubert, Marisa K. 分享 收藏
A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products Hubert, Mario; Yang, Dennis T.; Kwok, Stanley C.; Rios, Anacelia; Das, Tapan K.; Patel, Ankit; Wuchner, Klaus; Antochshuk, Valentyn; Junge, Friederike; Bou-Assaf, George M.; Cao, Shawn; Saggu, Miguel; Montrond, Luis; Afonina, Nataliya; Kolhe, Parag; Loladze, Vakhtang; Narhi, Linda 分享 收藏
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Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle Mathaes, Roman; Narhi, Linda; Hawe, Andrea; Matter, Anja; Bechtold-Peters, Karoline; Kenrick, Sophia; Kar, Sambit; Laskina, Olga; Carpenter, John; Cavicchi, Richard; Koepf, Ellen; Lewis, E. Neil; De Silva, Rukman; Ripple, Dean 分享 收藏
Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective Li, Jinjiang; Krause, Mary E.; Chen, Xiaodong; Cheng, Yuan; Dai, Weiguo; Hill, John J.; Huang, Min; Jordan, Susan; LaCasse, Daniel; Narhi, Linda; Shalaev, Evgenyi; Shieh, Ian C.; Thomas, Justin C.; Tu, Raymond; Zheng, Songyan; Zhu, Lily 分享 收藏
Chemical and Biophysical Characteristics of Monoclonal Antibody Solutions Containing Aggregates Formed during Metal Catalyzed Oxidation Narhi, Linda O.; Luo, Quanzhou; Wypych, Jette; Torosantucci, Riccardo; Hawe, Andrea; Fujimori, Kiyoshi; Nashed-Samuel, Yasser; Jawa, Vibha; Joubert, Marisa K.; Jiskoot, Wim 分享 收藏
Biological Characterization of a Stable Effector Functionless (SEFL) Monoclonal Antibody Scaffold in Vitro Liu, Ling; Jacobsen, Frederick W.; Everds, Nancy; Zhuang, Yao; Yu, Yan Bin; Li, Nianyu; Clark, Darcey; Mai Phuong Nguyen; Fort, Madeline; Narayanan, Padma; Kim, Kei; Stevenson, Riki; Narhi, Linda; Gunasekaran, Kannan; Bussiere, Jeanine L. 分享 收藏
Engineering an IgG Scaffold Lacking Effector Function with Optimized Developability 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 分享 收藏
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Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy Narhi, Linda O.; Corvari, Vincent; Ripple, Dean C.; Afonina, Nataliya; Cecchini, Irene; Defelippis, Michael R.; Garidel, Patrick; Herre, Andrea; Koulov, Atanas V.; Lubiniecki, Tony; Mahler, Hanns-Christian; Mangiagalli, Paolo; Nesta, Douglas; Perez-Ramirez, Bernardo; Polozova, Alla; Rossi, Mara; Schmidt, Roland; Simler, Robert; Singh, Satish; Spitznagel, Thomas M.; Weiskopf, Andrew; Wuchner, Klaus 分享 收藏
Physical Characterization and In Vitro Biological Impact of Highly Aggregated Antibodies Separated into Size-Enriched Populations by Fluorescence-Activated Cell Sorting Telikepalli, Srivalli; Shinogle, Heather E.; Thapa, Prem S.; Kim, Jae Hyun; Deshpande, Meghana; Jawa, Vibha; Middaugh, C. Russell; Narhi, Linda O.; Joubert, Marisa K.; Volkin, David B. 分享 收藏
Development of a Human Antibody Tolerant Mouse Model to Assess the Immunogenicity Risk Due to Aggregated Biotherapeutics 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 分享 收藏
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