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Neutralizing Antibody Sample Testing and Report Harmonization (vol 26, 80, 2024)Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; Delcarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏 Neutralizing Antibody Sample Testing and Report HarmonizationJani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; DelCarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏 Anti-drug Antibody Sample Testing and Reporting HarmonizationJani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura Schild; Ward, Bethany; Cowan, Kyra J.; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R.; Coble, Kelly; Dholakiya, Sanjay L.; Dusseault, Julie; Hays, Amanda; Herl, Carina; Hodsdon, Michael E.; Irvin, Susan C.; Kirshner, Susan; Kolaitis, Gerry; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D.; Moldovan, Ioana R.; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary-Lehmann, Magdalena; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Williams, William T.; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don 分享 收藏 
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