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

Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform

针对生物治疗药物研发过程中的免疫原性风险评估,制定个性化缓解措施并进行监测:欧洲免疫原性平台的建议

Grudzinska-Goebel, Joanna; Benstein, Karin; Bloem, Karien; Cowan, Kyra J; Gorovits, Boris; Jadhav, Maria; Janssen, Melody; Jawa, Vibha; Kiessling, Andrea; Kramer, Daniel; Kromminga, Arno; van der Linden, Marcel; Liu, Susana; Lotz, Gregor P; Luo, Linlin; Malisauskas, Mantas; Marban-Doran, Céline; Mytych, Daniel T; Oquendo Cifuentes, Elisa; Pippig, Susanne; Ribes, Sandra; Rouwette, Myrthe; Shao, Weiping; Tourdot, Sophie; Weldingh, Karin Nana; Snoeck, Veerle

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)

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

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

Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements

用于基因治疗的现有抗体检测:患者选择阈值和伴随诊断要求方面的考虑

Braun, Manuela; Lange, Claudia; Schatz, Philipp; Long, Brian; Stanta, Johannes; Gorovits, Boris; Tarcsa, Edit; Jawa, Vibha; Yang, Tong-Yuan; Lembke, Wibke; Miller, Nicole; McBlane, Fraser; Christodoulou, Louis; Yuill, Daisy; Milton, Mark

Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy

腺相关病毒基因治疗的细胞免疫反应评估

Gorovits, Boris; Azadeh, Mitra; Buchlis, George; Fiscella, Michele; Harrison, Travis; Havert, Mike; Janetzki, Sylvia; Jawa, Vibha; Long, Brian; Mahnke, Yolanda D; McDermott, Andrew; Milton, Mark; Nelson, Robert; Vettermann, Christian; Wu, Bonnie

A deep catalog of protein-coding variation in 985,830 individuals

对985,830个个体的蛋白质编码变异进行深入分析

Sun, Kathie Y; Bai, Xiaodong; Chen, Siying; Bao, Suying; Kapoor, Manav; Zhang, Chuanyi; Backman, Joshua; Joseph, Tyler; Maxwell, Evan; Mitra, George; Gorovits, Alexander; Mansfield, Adam; Boutkov, Boris; Gokhale, Sujit; Habegger, Lukas; Marcketta, Anthony; Locke, Adam; Kessler, Michael D; Sharma, Deepika; Staples, Jeffrey; Bovijn, Jonas; Gelfman, Sahar; Gioia, Alessandro Di; Rajagopal, Veera; Lopez, Alexander; Varela, Jennifer Rico; Alegre, Jesus; Berumen, Jaime; Tapia-Conyer, Roberto; Kuri-Morales, Pablo; Torres, Jason; Emberson, Jonathan; Collins, Rory; Cantor, Michael; Thornton, Timothy; Kang, Hyun Min; Overton, John; Shuldiner, Alan R; Cremona, M Laura; Nafde, Mona; Baras, Aris; Abecasis, Goncalo; Marchini, Jonathan; Reid, Jeffrey G; Salerno, William; Balasubramanian, Suganthi

Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation

确定临床研究样本中的抗药抗体亲和力可为评估免疫反应成熟度提供工具

Alison Joyce, Christopher Shea, Zhiping You, Boris Gorovits, Christopher Lepsy

Interplay between abiotic (drought) and biotic (virus) stresses in tomato plants

番茄植株中非生物胁迫(干旱)和生物胁迫(病毒)之间的相互作用

Mishra, Ritesh; Shteinberg, Moshik; Shkolnik, Doron; Anfoka, Ghandi; Czosnek, Henryk; Gorovits, Rena

Tomato Yellow Leaf Curl Virus (TYLCV) Promotes Plant Tolerance to Drought

番茄黄化曲叶病毒(TYLCV)促进植物耐旱性

Shteinberg, Moshik; Mishra, Ritesh; Anfoka, Ghandi; Altaleb, Miassar; Brotman, Yariv; Moshelion, Menachem; Gorovits, Rena; Czosnek, Henryk

Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays

利用总抗体检测评估腺相关病毒基因治疗方式的体液免疫反应

Gorovits, Boris; Azadeh, Mitra; Buchlis, George; Harrison, Travis; Havert, Mike; Jawa, Vibha; Long, Brian; McNally, Jim; Milton, Mark; Nelson, Robert; O'Dell, Mark; Richards, Karen; Vettermann, Christian; Wu, Bonnie