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Steven J. Swanson

genentech, inc. south san francisco

32H指数
120论文数
4.3K被引数
收录论文 28
发表时间
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)
err2026-01-01
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PREAI
errTounekti, 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
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Interpreting immunogenicity in oncology clinical trials在肿瘤学临床试验中解读免疫原性
err2025-08-25
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errOAAI
errPeter R. Galle; Martin Reck; David J. Pinato; Rosario Garcia-Campelo; Richard S. Finn; Sophie Cousin; Jim Zanghi; Coen A. Bernaards; Steven J. Swanson; Stefanie Morris; Yuan Song; Solange Peters
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Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates
err2024-07-15
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PREAI
errUsdin, Maxime; Quarmby, Valerie; Zanghi, James; Bernaards, Coen; Liao, Laura; Laxamana, Joel; Wu, Benjamin; Swanson, Steven; Song, Yuan; Siguenza, Patty
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QUANTITATIVE ASSESSMENT OF HLA CLASS I PRESENTATION IN ICT-107, A DENDRITIC CELL-BASED IMMUNOTHERAPY
err2016-09-01
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PREAI
errKaabinejadian, Saghar; Buchli, Rico; Swanson, Steven J.; Gringeri, Anthony J.; Weidanz, Jon A.; Hildebrand, William H.
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The quintessence of immunogenicity reporting for biotherapeutics
err2015-04-07
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errOAAI
errShankar, Gopi; Arkin, Steven; Devanarayan, Viswanath; Kromminga, Arno; Quarmby, Valerie; Richards, Susan; Subramanyam, Meena; Swanson, Steven
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A method to quantitate the neutralizing capacity of anti-therapeutic protein antibodies in serum and their correlation to clinical impact
err2015-01-01
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PREAI
errKaliyaperumal, Arunan; Pennucci, Jason; Nagatani, Janice; Juan, Gloria; Swanson, Steven; Gupta, Shalini
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Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations
err2014-04-24
err259
errOAAI
errShankar, 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.
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Immunogenicity assessment in non-clinical studies
err2012-06-01
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PREAI
errSwanson, Steven J.; Bussiere, Jeanine
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Strategy to confirm the presence of anti-erythropoietin neutralizing antibodies in human serum
err2011-07-01
err16
PREAI
errSanchez, Sergio; Barger, Troy; Zhou, Lei; Hale, Michael; Mytych, Daniel; Gupta, Shalini; Swanson, Steven J.; Civoli, Francesca
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Assessment of immunogenicity of romiplostim in clinical studies with ITP subjects
err2010-02-13
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errOAAI
errJawa, Vibha; Hokom, Martha; Hu, Zheng; El-Abaadi, Naglaa; Zhuang, Yao; Berger, Dietmar; Gupta, Shalini; Swanson, Steven J.; Chirmule, Narendra
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Comparing Exponentially Weighted Moving Average and Run Rules in Process Control of Semiquantitative Immunogenicity Immunoassays
err2009-12-10
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errOAAI
errBarger, Troy E.; Zhou, Lei; Hale, Michael; Moxness, Michael; Swanson, Steven J.; Chirmule, Narendra
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A Step-wise Approach for Transfer of Immunogenicity Assays during Clinical Drug Development
err2009-07-22
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errOAAI
errTatarewicz, Suzanna; Moxness, Michael; Weeraratne, Dohan; Zhou, Lei; Hale, Michael; Swanson, Steven J.; Chirmule, Narendra
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