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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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Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy 腺相关病毒基因治疗的细胞免疫应答评价 Gorovits, Boris; Azadeh, Mitra; Buchlis, George; Fiscella, Michele; Harrison, Travis; Havert, Mike; Janetzki, Sylvia; Jawa, Vibha; Long, Brian; Mahnke, Yolanda D.; McDermott, Andrew; Milton, Mark; Nelson, Robert; Vettermann, Christian; Wu, Bonnie 分享 收藏
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When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform COMMENT Lotz, Gregor P.; Benstein, Karin; Bloem, Karien; Buddiger, Harm; Calonder, Claudio; Elm, Stefanie; Fernandez, Elena; Goodman, Joanne; Gorovits, Boris; Grudzinska-Goebel, Joanna; Janssen, Melody; Jawa, Vibha; Kramer, Daniel; Luo, Linlin; Malisauskas, Mantas; Michaut, Lydia; Schaefer, Martin; Spindeldreher, Sebastian; Ullmann, Martin; Nana Weldingh, Karin; Kromminga, Arno; Snoeck, Veerle 分享 收藏
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays Gorovits, Boris; Azadeh, Mitra; Buchlis, George; Harrison, Travis; Havert, Mike; Jawa, Vibha; Long, Brian; McNally, Jim; Milton, Mark; Nelson, Robert; O'Dell, Mark; Richards, Karen; Vettermann, Christian; Wu, Bonnie 分享 收藏
Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling Wang, Ying; Crowell, Sarah J.; Joyce, Alison; Dyleski, Lisa; Messing, Dean; Cargill, Jennifer; You, Zhiping; Murphy, Sarah; Gomes, Meghan; Gorovits, Boris 分享 收藏
AAPS Perspective on the EURL Recommendation on the use of Non-Animal-Derived Antibodies Gorovits, 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
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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
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