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收藏分享 收藏 Immunogenicity Risk Assessment of Process-Related Impurities in An Engineered T Cell Receptor Cellular Product
Mora, Johanna; Forman, Daron; Hu, Jennifer; Ijantkar, Akshata; Gokemeijer, Jochem; Kolaja, Kyle L.; Picarillo, Caryn; Jawa, Vibha; Yue, Hai; Lamy, Juliette; Denies, Sofie; Schockaert, Jana; Ackaert, Chloe 分享 收藏 Bioanalytical Methods for Characterization of CAR-T Cellular Kinetics: Comparison of PCR Assays and MatricesMasilamani, Madhan; Jawa, Vibha; Dai, Yanshan; Das, Romita; Park, Alice; Lamba, Manisha; Wu, Fan; Zheng, Xirong; Lu, Edwin; Gleason, Carol; Mack, Tim; Mora, Johanna; Surapaneni, Sekhar 分享 收藏 Neutralizing Antibody Validation Testing and Reporting HarmonizationMyler, Heather; Pedras-Vasconcelos, Joao; Lester, Todd; Civoli, Francesca; Xu, Weifeng; Wu, Bonnie; Vainshtein, Inna; Luo, Linlin; Hassanein, Mohamed; Liu, Susana; Ramaswamy, Swarna Suba; Mora, Johanna; Pennucci, Jason; McCush, Fred; Lavelle, Amy; Jani, Darshana; Ambakhutwala, Angela; Baltrukonis, Daniel; Barker, Breann; Carmean, Rebecca; Chung, Shan; Dai, Sheng; DeWall, Stephen; Dholakiya, Sanjay L.; Dodge, Robert; Finco, Deborah; Yan, Haoheng; Hays, Amanda; Hu, Zheng; Inzano, Cynthia; Kamen, Lynn; Lai, Ching-Ha; Meyer, Erik; Nelson, Robert; Paudel, Amrit; Phillips, Kelli; Poupart, Marie-Eve; Qu, Qiang; Abhari, Mohsen Rajabi; Ryding, Janka; Sheldon, Curtis; Spriggs, Franklin; Warrino, Dominic; Wu, Yuling; Yang, Lin; Pasas-Farmer, Stephanie 分享 收藏 分享 收藏 分享 收藏 Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry ConsortiumManning, Marta Starcevic; Hassanein, Mohamed; Partridge, Michael A.; Jawa, Vibha; Mora, Johanna; Ryman, Josiah; Barker, Breann; Braithwaite, Christian; Carleton, Kevin; Hay, Laura; Hottenstein, Charles; Kubiak, Robert J.; Devanarayan, Viswanath 分享 收藏 AAPS Perspective on the EURL Recommendation on the use of Non-Animal-Derived AntibodiesGorovits, B.; Hays, A.; Jani, D.; Jones, C.; King, C.; Lundequist, A.; Mora, J.; Partridge, M.; Pathania, D.; Ramaswamy, S. S.; Rutwij, D.; Shen, H.; Starling, G. 分享 收藏 分享 收藏 分享 收藏 An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of ElotuzumabPassey, Chaitali; Mora, Johanna; Dodge, Robert; Gibiansky, Leonid; Sheng, Jennifer; Roy, Amit; Bello, Akintunde; Gupta, Manish 分享 收藏 分享 收藏 分享 收藏 分享 收藏 分享 收藏 
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