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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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The spatial ventricular gradient is a non-invasive, vectorcardiographic correlate of cardiac fibrosis 空间心室梯度是一种非侵入性的心向量心电图学相关指标，用于反映心脏纤维化。 Stabenau, Hans F.; Matos, Jason D.; Kramer, Daniel B.; Sau, Arunashis; Pastika, Libor; Sieliwonczyk, Ewa; Patlatzoglou, Konstantinos; Peters, Nicholas S.; Tung, Patricia; Ng, Fu Siong; Nezafat, Reza; Waks, Jonathan W. 分享 收藏
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Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals Tourdot, Sophie; Baltrunkonis, Daniel; Denies, Sofie; Devanarayan, Viswanath; Grudzinska-Goebel, Joanna; Kromminga, Arno; Lotz, Gregor P.; Malherbe, Laurent; Michaut, Lydia; Weldingh, Karin N.; Pedras-Vasconcelos, Joao A.; Salazar-Fontana, Laura. I.; Spindeldreher, Sebastian; Sauna, Zuben; Snoeck, Veerle; Verthelyi, Daniela; Kramer, Daniel 分享 收藏
Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial Shah, Viral N.; Al-Karadsheh, Amer; Barnes, Cathy; Mandry, Jose; Nakhle, Samer; Wernicke-Panten, Karin; Kramer, Daniel; Schmider, Wolfgang; Pierre, Suzanne; Teichert, Lenore; Rotthaeuser, Baerbel; Mukherjee, Bhaswati; Bailey, Timothy S. 分享 收藏
Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial Shah, Viral N.; Al-Karadsheh, Amer; Barnes, Cathy; Mandry, Jose; Nakhle, Samer; Wernicke-Panten, Karin; Kramer, Daniel; Schmider, Wolfgang; Pierre, Suzanne; Teichert, Lenore; Rotthaeuser, Baerbel; Mukherjee, Bhaswati; Bailey, Timothy S. 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
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