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 分享 收藏
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Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates Usdin, Maxime; Quarmby, Valerie; Zanghi, James; Bernaards, Coen; Liao, Laura; Laxamana, Joel; Wu, Benjamin; Swanson, Steven; Song, Yuan; Siguenza, Patty 分享 收藏
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Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations Shankar, G.; Arkin, S.; Cocea, L.; Devanarayan, V.; Kirshner, S.; Kromminga, A.; Quarmby, V.; Richards, S.; Schneider, C. K.; Subramanyam, M.; Swanson, S.; Verthelyi, D.; Yim, S. 分享 收藏
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