未登录 分享 收藏
分享 收藏
分享 收藏
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
Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future Wuchner, Klaus; Yi, Linda; Chery, Cyrille; Nikels, Felix; Junge, Friederike; Crotts, George; Rinaldi, Gianluca; Starkey, Jason A.; Bechtold-Peters, Karoline; Shuman, Melissa; Leiss, Michael; Jahn, Michael; Garidel, Patrick; de Ruiter, Rien; Richer, Sarah M.; Cao, Shawn; Peuker, Sebastian; Huille, Sylvain; Wang, Tingting; Le Brun, Virginie 分享 收藏
Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates Wuchner, Klaus; Yi, Linda; Chery, Cyrille; Nikels, Felix; Junge, Friederike; Crotts, George; Rinaldi, Gianluca; Starkey, Jason A.; Bechtold-Peters, Karoline; Shuman, Melissa; Leiss, Michael; Jahn, Michael; Garidel, Patrick; de Ruiter, Rien; Richer, Sarah M.; Cao, Shawn; Peuker, Sebastian; Huille, Sylvain; Wang, Tingting; Le Brun, Virginie 分享 收藏
分享 收藏
分享 收藏
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
分享 收藏
分享 收藏
Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab Seo, Neungseon; Polozova, Alla; Zhang, Mingxuan; Yates, Zachary; Cao, Shawn; Li, Huimin; Kuhns, Scott; Maher, Gwendolyn; McBride, Helen J.; Liu, Jennifer 分享 收藏
分享 收藏
分享 收藏
分享 收藏