未登录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 .png)
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收藏IQ Survey Results on Current Industry Practices-Part 1: Immunogenicity Risk AssessmentGrimaldi, Christine; Richards, Susan; Baltrukonis, Daniel; Sims Belouski, Shelley; Coble, Kelly; Dholakiya, Sanjay L.; Grudzinska-Goebel, Joanna; Kolaitis, Gerry; Leu, Jocelyn H.; Luo, Linlin; Lowe, Stephen; Niu, Tao; Toft-Hansen, Henrik; Yang, Jianning; Wu, Benjamin 分享 收藏 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 Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis抗药物抗体测定验证: 通过更简单的阳性对照回收率数据分析改进测定选择性的报告Gorovits, Boris; Roldan, Marcela Araya; Baltrukonis, Daniel; Cai, Chun-Hua; Donley, Jean; Jani, Darshana; Kamerud, John; McCush, Frederick; Thomas, Jeffrey S.; Wang, Ying 分享 收藏 Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab临床研究中用于检测阿达木单抗和英夫利昔单抗抗药物抗体的免疫测定方法Gorovits, B.; Baltrukonis, D. J.; Bhattacharya, I; Birchler, M. A.; Finco, D.; Sikkema, D.; Vincent, M. S.; Lula, S.; Marshall, L.; Hickling, T. P. 分享 收藏 Pharmacokinetics and pharmacodynamics of PF-05231023, a novel long-acting FGF21 mimetic, in a first-in-human studyDong, Jennifer Q.; Rossulek, Michelle; Somayaji, Veena R.; Baltrukonis, Daniel; Liang, Yali; Hudson, Krischan; Hernandez-Illas, Martha; Calle, Roberto A. 分享 收藏 分享 收藏 分享 收藏 分享 收藏 
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