日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

Estimated Efficacy of TAK-003 Against Asymptomatic Dengue Infection in Children and Adolescents Participating in the DEN-301 Trial in Asia Pacific and Latin America.

TAK-003 对参与 DEN-301 试验的亚太和拉丁美洲儿童和青少年无症状登革热感染的估计疗效

El Hindi Tarek, Alera Maria Theresa, Bravo Lulu, Moreira Edson Duarte Jr, Dietze Reynaldo, Oliveira Ana Lucia, Watanaveeradej Veerachai, Zhao Yuan, Sonderegger Ivo, Tricou Vianney, Folschweiller Nicolas, Biswal Shibadas

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immun

2024 年生物分析最新问题白皮书:免疫原性评估超越 ADA/NAb 的演变;受监管的基因组/NGS 检测;超敏反应;最小噪声抑制;假阳性范围;现代化疫苗方法;NAb/TAb 相关性(第 3A 部分 - 关于基因治疗、细胞治疗、疫苗的分子检测和免疫原性的高级策略建议;生物治疗免疫原性评估和临床相关性;第 3B 部分 - 监管机构对免疫原性评估的意见)

Tounekti, Omar; Prior, Sandra; Wassmer, Sarah; Xu, Joshua; Wong, Adrian; Fang, Xiaodong; Sonderegger, Ivo; Smeraglia, John; Huleatt, James; Loo, LiNa; Beaver, Christopher; DelCarpini, Jason; Dessy, Francis; Diebold, Sandra; Fiscella, Michele; Garofolo, Fabio; Grimaldi, Christine; Gupta, Swati; Hou, Victor; Irwin, Chad; Jani, Dewal; Joseph, Julie; Kalina, Warren; Kar, Sumit; Kavita, Uma; Lu, Yanmei; Marshall, Jean-Claude; Mayer, Christian; Mora, Johanna; Nolan, Katrina; Peng, Kun; Riccitelli, Nathan; Scully, Ingrid; Seitzer, Jessica; Stern, Mark; Wadhwa, Meenu; Xu, Yuanxin; Verthelyi, Daniela; Sumner, Giane; Clements-Egan, Adrienne; Chen, Cecil; Gorovits, Boris; Torri, Albert; Baltrukonis, Daniel; Gunn, George; Ishii-Watabe, Akiko; Kramer, Daniel; Kubiak, Robert J; Mullins, Garrett; Pan, Luying; Partridge, Michael A; Poetzl, Johann; Rasamoelisolo, Michele; Sirtori, Federico Riccardi; Richards, Susan; Saad, Ola M; Shao, Weiping; Song, Yuan; Song, Sam; Staack, Roland F; Wu, Bonnie; Manangeeswaran, Mohanraj; Thacker, Seth

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)

2023 年生物分析最新问题白皮书:ADA 检测的 ISR、dPCR 与 qPCR 的兴起、疫苗检测的国际参考标准、抗 AAV TAb 给药后评估、NanoString 验证、ELISpot 作为金标准(第三部分 - 关于基因治疗、细胞治疗、疫苗免疫原性和技术的建议;生物治疗免疫原性和风险评估;ADA/NAb 检测/报告协调)

Mora, Johanna; Palmer, Rachel; Wagner, Leslie; Wu, Bonnie; Partridge, Michael; Meena; Sonderegger, Ivo; Smeraglia, John; Bivi, Nicoletta; Dakappagari, Naveen; Diebold, Sandra; Garofolo, Fabio; Grimaldi, Christine; Kalina, Warren; Kamerud, John; Kar, Sumit; Marshall, Jean-Claude; Mayer, Christian; Melton, Andrew; Merdek, Keith; Nolan, Katrina; Picard, Serge; Shao, Weiping; Seitzer, Jessica; Tanaka, Yoichi; Tounekti, Omar; Vigil, Adam; Walravens, Karl; Xu, Joshua; Xu, Weifeng; Xu, Yuanxin; Yang, Lin; Zhu, Liang; Verthelyi, Daniela; Kubiak, Robert J; Coble, Kelly; Gupta, Swati; Abhari, Mohsen Rajabi; Richards, Susan; Song, Yuan; Ullmann, Martin; Calderon, Boris; Cludts, Isabelle; Gunn, George R; Gupta, Shalini; Ishii-Watabe, Akiko; Manangeeswaran, Mohanraj; Maxfield, Kimberly; McCush, Fred; O'Day, Christine; Peng, Kate; Poetzl, Johann; Rasamoelisolo, Michele; Saad, Ola M; Scheibner, Kara; Shubow, Sophie; Song, Sam; Thacker, Seth

Harmonization of Vaccine Ligand Binding Assays Validation

疫苗配体结合试验验证的协调统一

Dessy, Francis; Sonderegger, Ivo; Wagner, Leslie; Buoninfante, Alessandra; Wadhwa, Meenu; Agnes, Joseph; Aksyuk, Anastasia; Baclin, Angelique; Bonhomme, Marie; Cloney-Clark, Shane; Corsaro, Bart; Neto, João Tavares; Fries, Louis; Gagnon, Luc; Garofolo, Fabio; Giardina, Peter; Green, Tina; Guimera, Nuria; Harris, Shannon; Helmy, Roy; Huleatt, James; Ishii-Watabe, Akiko; Jaeger, Ralf; Jani, Dewal; Janssen, Sarah; Kierstead, Lisa; Makar, Karen; Marshall, Jean-Claude; Mayer, Christian; Mendes, Dulcyane Neiva; Murphy, Rocio; Nadarajah, Sankeetha; Nolan, Katrina; Plested, Joyce; Scully, Ingrid; Solstad, Therese; Stoop, Jeroen; Tan, Charles; Verch, Thorsten; Wilkins, Deidre; Xu, Arron; Zheng, Lingyi; Zhu, Mingzhu

Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study

阿达木单抗生物类似药BI 695501与阿达木单抗参考产品在治疗中重度活动性类风湿关节炎患者方面具有相似的疗效、安全性和免疫原性:来自III期随机VOLTAIRE-RA等效性研究的结果

Cohen, Stanley B; Alonso-Ruiz, Alberto; Klimiuk, Piotr A; Lee, Eric C; Peter, Nuala; Sonderegger, Ivo; Assudani, Deepak

Similar Pharmacokinetics of the Adalimumab (Humira(®)) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE(®)-AI and VOLTAIRE(®)-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials

阿达木单抗(Humira®)生物类似药BI 695501通过皮下自动注射器或预充式注射器(VOLTAIRE®-AI和VOLTAIRE®-TAI)给药时的药代动力学相似性:1期随机、开放标签、平行组试验

Ramael, Steven; Van Hoorick, Benjamin; Tiessen, Renger; van Iersel, Thijs; Moschetti, Viktoria; Lang, Benjamin; Sonderegger, Ivo; Wiebe, Sabrina; Liedert, Bernd; Jayadeva, Girish

Orchestration of B and T cell responses in health and disease by common gamma chain family cytokines with a focus on IL-21

常见γ链家族细胞因子(以IL-21为重点)在健康和疾病状态下对B细胞和T细胞反应的调控

Limon-Flores, Alberto Yairh; Perez-Tapia, Mayra; Estrada-Garcia, Iris; Vaughan, Gilberto; Escobar-Gutierrez, Alejandro; Calderon-Amador, Juana; Herrera-Rodriguez, Sara Elisa; Brizuela-Garcia, Adriana; Heras-Chavarria, Monica; Flores-Langarica, Adriana; Cedillo-Barron, Leticia; Flores-Romo, Leopoldo; Kopf, Manfred; Tortola, Luigi; Schmitz, Iwana; Fröhlich, Anja; Sonderegger, Ivo; Pawelski, Helga; Schneider, Christoph

CD40-CD40L cross-talk integrates strong antigenic signals and microbial stimuli to induce development of IL-17-producing CD4+ T cells

CD40-CD40L 相互作用整合了强烈的抗原信号和微生物刺激,从而诱导产生 IL-17 的 CD4+ T 细胞的发育。

Iezzi, Giandomenica; Sonderegger, Ivo; Ampenberger, Franziska; Schmitz, Nicole; Marsland, Benjamin J; Kopf, Manfred

Activation of dendritic cells through the interleukin 1 receptor 1 is critical for the induction of autoimmune myocarditis

白细胞介素 1 受体 1 介导的树突状细胞活化对于自身免疫性心肌炎的发生至关重要。

Eriksson, Urs; Kurrer, Michael O; Sonderegger, Ivo; Iezzi, Giandomenica; Tafuri, Anna; Hunziker, Lukas; Suzuki, Shinobu; Bachmaier, Kurt; Bingisser, Roland M; Penninger, Josef M; Kopf, Manfred