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 Biothera
2025 年生物分析最新问题白皮书：AAV 基因治疗患者的重复给药；细胞因子释放综合征 (CRS) 免疫原性风险；脱落检测；非人灵长类动物 (NHP) 研究的免疫原性；CMC 与生物分析检测；人工智能驱动的 NGS 基因组流程（第 3A 部分 - 关于基因、细胞和疫苗疗法免疫原性及技术的建议；生物治疗药物和生物类似药的免疫原性评估及临床相关性；第 3B 部分 - 监管机构对 Biothera 免疫原性/技术的意见）
期刊:Bioanalysis
影响因子:1.8
doi:10.1080/17576180.2025.2586976
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
