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2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A-Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B-Regulatory Agencies Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies) 2025年生物分析近期问题白皮书：AAV基因治疗患者的重复给药；CRS免疫原性风险；脱落检测；非人灵长类动物研究免疫原性；CMC与生物分析检测；人工智能驱动的基因组NGS分析流程（第3A部分—基因、细胞和疫苗治疗免疫原性及技术的建议；生物药与生物类似药免疫原性评估及临床相关性；第3B部分—监管机构对生物药、基因、细胞及疫苗治疗免疫原性/技术的意见） Tounekti, Omar; Shubow, Sophie; Wassmer, Sarah; Van Tuyl, Andrea; Yang, Lin; Gong, Binsheng; Abhari, Mohsen Rajabi; Kalina, Warren; Myler, Heather; DelCarpini, Jason; Escobar, David; Fiscella, Michele; Gorovits, Boris; Gupta, Swati; Irvin, Susan C.; Irwin, Chad; Jankowski, Wojciech; Jawa, Vibha; Karauzum, Hatice; Kerridge, Claire; Lu, Yanmei; Mayer, Christian; Mcgregor, Jessica; Melton, Andrew; Murphy, Rocio; Nanra, Jasdeep; Nowocin, Anna; Partridge, Michael A.; Prior, Sandra; Sauna, Zuben; Scott, Bradley; Seitzer, Jessica; Stern, Mark; Sugimoto, Hiroshi; Taylor, Melissa; Wong, Adrian; Xiao, Wenming; Xu, Yuanxin; Yang, Tong-Yuan; Yuill, Daisy; Kubiak, Robert J.; Thway, Theingi; Gunn, George; Pelto, Ryan; Sumner, Giane; Baltrukonis, Daniel; Dholakiya, Sanjay L.; Dogmanits, Shannon; Garofolo, Fabio; Jadhav, Maria; Kramer, Daniel; Meyer, Erik; Mohapatra, Susovan; Mozaffari, Reza; Peng, Kun; Pine, Samuel; Poetzl, Johann; Rasamoelisolo, Michele; Shao, Weiping; Staack, Roland F.; Swanson, Steven; Taqui, Atiya; Vauleon, Stephanie; Wang, Yun; Wen, Yi 分享 收藏
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DB-OTO Gene Therapy for Inherited Deafness Valayannopoulos, V.; Bance, M.; Carvalho, D.S.; Greinwald, J.H.; Harvey, S.A.; Ishiyama, A.; Landry, E.C.; Löwenheim, H.; Lustig, L.R.; Manrique, M.; et al. DB-OTO基因疗法用于遗传性耳聋。N. Engl. J. Med. 2025. [Google Scholar] [CrossRef] Valayannopoulos, Vassili; Bance, Manohar; Carvalho, Daniela S.; Greinwald Jr, John H.; Harvey, Steven A.; Ishiyama, Akira; Landry, Evie C.; Lowenheim, Hubert; Lustig, Lawrence R.; Manrique, Manuel; Nash, Robert; Polo, Ruben; Pritchett, Cedric V.; Rubinstein, Jay T.; Shearer, A. Eliot; del Castillo, Ignacio; Anderson, Jeffery J.; Corrales, C. Eduardo; Quigley, Tera M.; Riggs, William J.; Weber, Peter; Wilson, Gary; Irvin, Susan C.; Hassan, Hazem E.; Chen, Yanping; Liu, Rong; Drummond, Meghan C.; Sabin, Leah R.; Musser, Bret J.; Yancopoulos, George D.; Kyratsous, Christos A.; Herman, Gary A.; Baras, Aris; Whitton, Jonathon P. 分享 收藏
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials Lai, Ching-Ha; Chen, Mu; Fraser, Sasha; Wang, Jessica; Mcafee, Sean; Speaks, Emma; Simeone, Nicholas; Rodriguez, Jacqueline; Stefan, Colin; Destefano, Lisa; Elango, Chinnasamy; Andisik, Matthew D.; Sumner, Giane; Zhao, An; Irvin, Susan C.; Torri, Albert; Partridge, Michael A. 分享 收藏
Neutralizing Antibody Sample Testing and Report Harmonization (vol 26, 80, 2024) Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; Delcarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏
Neutralizing Antibody Sample Testing and Report Harmonization Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; DelCarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏
Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development Davis, John D.; Padros, Marcal Bravo; Conrado, Daniela J.; Ganguly, Samit; Guan, Xiaowen; Hassan, Hazem E.; Hazra, Anasuya; Irvin, Susan C.; Jayachandran, Priya; Kosloski, Matthew P.; Lin, Kuan-Ju; Mukherjee, Kamalika; Paccaly, Anne; Papachristos, Apostolos; Partridge, Michael A.; Prabhu, Saileta; Visich, Jennifer; Welf, Erik S.; Xu, Xiaoying; Zhao, An; Zhu, Min 分享 收藏
Anti-drug Antibody Sample Testing and Reporting Harmonization Jani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura Schild; Ward, Bethany; Cowan, Kyra J.; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R.; Coble, Kelly; Dholakiya, Sanjay L.; Dusseault, Julie; Hays, Amanda; Herl, Carina; Hodsdon, Michael E.; Irvin, Susan C.; Kirshner, Susan; Kolaitis, Gerry; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D.; Moldovan, Ioana R.; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary-Lehmann, Magdalena; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Williams, William T.; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don 分享 收藏
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy Irvin, Susan C.; D'Orvilliers, Amanda; Bloch, Nicolin; Boccio, Kayla; Pennucci, Jason; Brouwer-Visser, Jurriaan; Ullman, Erica; Rajadhyaksha, Manoj; Hassanein, Mohamed; Potocky, Terra; Torri, Albert; Hermann, Aynur; Partridge, Michael A. 分享 收藏
Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays Dengler, Andrew F.; Weiss, Rachel; Truong, Tiffany; Irvin, Susan C.; Gadhia, Nidhi; Hassanein, Mohamed; Georgaros, Camille; Taylor, Jessica-Ann; Paccaly, Anne; Sumner, Giane; Andisik, Matthew D.; Torri, Albert; Partridge, Michael A. 分享 收藏
Liquid Chromatography-Multiple Reaction Monitoring-Mass Spectrometry Assay for Quantitative Measurement of Therapeutic Antibody Cocktail REGEN-COV Concentrations in COVID-19 Patient Serum Zhong, Xuefei; Nayak, Shruti; Guo, Lili; Raidas, Shivkumar; Zhao, Yunlong; Weiss, Rachel; Andisik, Matthew; Elango, Chinnasamy; Sumner, Giane; Irvin, Susan C.; Partridge, Michael A.; Yan, Hong; Yen, Sook E.; Qiu, Haibo; Mao, Yuan; Torri, Albert; Li, Ning 分享 收藏
An ITAM in a Nonenveloped Virus Regulates Activation of NF-κB, Induction of Beta Interferon, and Viral Spread Stebbing, Rachael E.; Irvin, Susan C.; Rivera-Serrano, Efran E.; Boehme, Karl W.; Ikizler, Mine; Yoder, Jeffrey A.; Dermody, Terence S.; Sherry, Barbara 分享 收藏
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