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
Stability Comparison Between Microglassi fi cation and Lyophilization Using a Monoclonal Antibody Chandrababu, Karthik Balakrishna; Kannan, Aadithya; Savage, John R.; Stadmiller, Samantha; Ryle, Adam E.; Cheung, Chloe; Kelley, Robert F.; Maa, Yuh-fun; Saggu, Miguel; Bitter, Deborah L. 分享 收藏
Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection-Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility Mazaheri, Maryam; Saggu, Miguel; Wuchner, Klaus; Koulov, Atanas V.; Nikels, Felix; Das, Tapan K.; Chalus, Pascal; Cash, Patricia W.; Finkler, Christof; Levitskaya-Seaman, Sophia V.; Case, John; Parsons, Jonny; Gonzalez, Kristen 分享 收藏
Probing the Protein-Excipient Interaction in the Orally Delivered Protein by Solid-State Hydrogen-Deuterium Exchange Mass Spectrometry and Molecular Dynamics Pan, Xiao; Lenka, Sunidhi; Davis, Jeff; Nagapudi, Karthik; Mantik, Priscilla; Saggu, Miguel; Dai, Lulu; Cadang, Lance; Zhang, Hui-Min; Zhang, Jennifer; Izadi, Saeed; Yang, Feng; Wei, Bingchuan 分享 收藏
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An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards Telikepalli, Srivalli N.; Carrier, Michael J.; Ripple, Dean C.; Barnett, Greg; Bhirde, Ashwinkumar; Bolton, Donna; Bou-Assaf, George M.; Ferrari, Erica; Leigh, Scott; Levitskaya-Seaman, Sophia; Menzen, Tim; Nikels, Felix; Riley, Anna; Saggu, Miguel; Sahni, Neha; Vernooij, Eric; Wuchner, Klaus 分享 收藏
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An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion Benkstein, Kurt D.; Balakrishnan, Gurusamy; Bhirde, Ashwinkumar; Chalus, Pascal; Das, Tapan K.; Do, Ngoc; Duewer, David L.; Filonov, Nazar; Cheong, Fook Chiong; Garidel, Patrick; Gill, Nicole S.; Grabarek, Adam D.; Grier, David G.; Hadley, Judith; Hollingsworth, Andrew D.; Howard, Wesley W.; Jarzebski, Maciej; Jiskoot, Wim; Kar, Sambit R.; Kestens, Vikram; Khasa, Harshit; Kim, Yoen Joo; Koulov, Atanas; Matter, Anja; Philips, Laura A.; Probst, Christine; Ramaye, Yannic; Randolph, Theodore W.; Ripple, Dean C.; Romeijn, Stefan; Saggu, Miguel; Schleinzer, Franziska; Snell, Jared R.; Tatarkiewicz, Jan Kuba; Wright, Heather Anne; Yang, Dennis T. 分享 收藏
Multi-attribute Raman spectroscopy (MARS) for monitoring product quality attributes in formulated monoclonal antibody therapeutics Wei, Bingchuan; Woon, Nicholas; Dai, Lu; Fish, Raphael; Tai, Michelle; Handagama, Winode; Yin, Ashley; Sun, Jia; Maier, Andrew; McDaniel, Dana; Kadaub, Elvira; Yang, Jessica; Saggu, Miguel; Woys, Ann; Pester, Oxana; Lambert, Danny; Pell, Alex; Hao, Zhiqi; Magill, Gordon; Yim, Jack; Chan, Jefferson; Yang, Lindsay; Macchi, Frank; Bell, Christian; Deperalta, Galahad; Chen, Yan 分享 收藏
Evaluating a Modified High Purity Polysorbate 20 Designed to Reduce the Risk of Free Fatty Acid Particle Formation Doshi, Nidhi; Ritchie, Kyle; Shobha, Tamanna; Giddings, Jamie; Gregoritza, Kathrin; Taing, Rosalynn; Rumbelow, Stephen; Chu, Jeff; Tomlinson, Anthony; Kannan, Aadithya; Saggu, Miguel; Cai, Si Kai; Nicoulin, Victor; Liu, Wenqiang; Russell, Steve; Luis, Lin; Yadav, Sandeep 分享 收藏
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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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A unique iron-sulfur cluster is crucial for oxygen tolerance of a [NiFe]-hydrogenase Goris, Tobias; Wait, Annemarie F.; Saggu, Miguel; Fritsch, Johannes; Heidary, Nina; Stein, Matthias; Zebger, Ingo; Lendzian, Friedhelm; Armstrong, Fraser A.; Friedrich, Baerbel; Lenz, Oliver 分享 收藏