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

The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring.

世界卫生组织首个英夫利昔单抗抗药抗体参考小组:朝着统一治疗药物监测迈出的一步

Wadhwa Meenu, Cludts Isabelle, Atkinson Eleanor, Rigsby Peter

2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)

2023 年生物分析最新问题白皮书:欧盟 IVDR 2017/746 的实施/影响、体外诊断/伴随诊断/CLIA 批准的检测方法、高维细胞术、多重分析技术、LBA 组织分析、疫苗研究终点、用于生物标志物的细胞检测、细胞疗法和疫苗(第二部分 - 关于生物标志物、体外诊断、伴随诊断、细胞检测、流式细胞术、配体结合和酶检测的开发和验证的建议;先进关键试剂策略)

Kholmanskikh, Olga; Wang, Yow-Ming; Hersey, Sarah; Wadhwa, Meenu; Block, Katherine; Bandukwala, Abbas; Szapacs, Matthew; Weiner, Russell; Awwad, Khader; Dessy, Francis; Downing, Sean; Du, Xiulian; Garofolo, Fabio; Harris, Shannon; Hou, Victor; Jones, Jennifer; Kar, Sumit; Kinhikar, Arvind; Li, Ming; Mathews, Joel; Meissen, John; Sumner, Giane Oliveira; Pan, Luying; Sanderink, Gerard; Scully, Ingrid; Stanta, Johannes; Tanaka, Yoichi; Vauleon, Stephanie; Wagner, Leslie; Wang, Kai; Zhu, Liang; Eck, Steven; Lin, Yi-Dong; Azadeh, Mitra; Decman, Vilma; Diebold, Sandra; Du, Xiulian; Goihberg, Polina; Alcaide, Enrique Gomez; Gonneau, Christele; Hedrick, Michael Nathan; Hopkins, Gregory; Kar, Sumit; Loschko, Jakob; McCausland, Megan; Mendez, Luis; Sehra, Sarita; Stevens, Erin; Sun, Yongliang Steve; Tangri, Shabnam; Trampont, Paul C; Cludts, Isabelle; Dysinger, Mark; Kavita, Uma; Sugimoto, Hiroshi; Chilewski, Shannon; Grimaldi, Christine; Jiang, Yong; Kamerud, John; Liu, Susana; Owen, Carolina; Palackal, Nisha; Petit-Frere, Corinne; Pine, Samuel; Abhari, Mohsen Rajabi; Scheibner, Kara; Williams, LaKenya; Xu, Tao; Zhang, Guodong

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

2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunog

2023年生物分析最新问题白皮书:氘代药物;脂质纳米颗粒;肿瘤/FFPE活检;靶向蛋白质组学;小分子共价抑制剂;手性生物分析;远程监管评估;样品核对/监管链(第一部分A - 关于质谱、色谱、样品制备的最新进展、挑战和解决方案以及BMV/受监管生物分析的建议;第一部分B - 监管机构对受监管生物分析/BMV、生物标志物/体外诊断/伴随诊断/生物活性物质、免疫学的意见)

Baratta, Mike; Jian, Wenying; Hengel, Shawna; Kaur, Surinder; Cunliffe, Jennifer; Boer, Jason; Hughes, Nicki; Kar, Sumit; Kellie, John; Kim, Yeoun Jin; Lassman, Michael; Mehl, John; Morgan, Ling; Palandra, Joe; Sarvaiya, Hetal; Zeng, Jianing; Zheng, Naiyu; Wang, Jian; Yuan, Long; Ji, Allena; Kochansky, Christopher; Tao, Lin; Huang, Yue; Maes, Estelle; Barbero, Luca; Contrepois, Kevin; Ferrari, Luca; Fu, Yunlin; Johnson, Jay; Jones, Barry; Kansal, Monika; Lu, Yang; Post, Noah; Shen, Honglue Holly; Xue, Yongjun Y-J; Zhang, Yiyue Cynthia; Biswas, Gopa; Cho, Seongeun Julia; Edmison, Anna; Benson, Kimberly; Abberley, Lee; Azadeh, Mitra; Francis, Jennifer; Garofolo, Fabio; Gupta, Shalini; Ivanova, Iordanka Dany; Ishii-Watabe, Akiko; Karnik, Shane; Kassim, Sean; Kavetska, Olga; Keller, Steve; Kossary, Elham; Li, Wenkui; McCush, Fred; Mendes, Dulcyane Neiva; Abhari, Mohsen Rajabi; Scheibner, Kara; Sikorski, Timothy; Staack, Roland F; Tabler, Edward; Tang, Huaping; Wan, Katty; Wang, Yow-Ming; Whale, Emma; Yang, Li; Zimmer, Jennifer; Bandukwala, Abbas; Du, Xiulian; Kholmanskikh, Olga; Gijsel, Sonja Kwadijk-de; Wadhwa, Meenu; Xu, Joshua; Buoninfante, Alessandra; Cludts, Isabelle; Diebold, Sandra; Maxfield, Kimberly; Mayer, Christian; Pedras-Vasconcelos, Joao; Abhari, Mohsen Rajabi; Shubow, Sophie; Tanaka, Yoichi; Tounekti, Omar; Verthelyi, Daniela; Wagner, Leslie

The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring

世卫组织首个阿达木单抗国际标准:生物活性和治疗药物监测的双重作用

Meenu Wadhwa, Chris Bird, Eleanor Atkinson, Isabelle Cludts, Peter Rigsby

Variation of PEAR1 DNA methylation influences platelet and leukocyte function

PEAR1 DNA甲基化的变异影响血小板和白细胞功能

Izzi, Benedetta; Gianfagna, Francesco; Yang, Wen-Yi; Cludts, Katrien; De Curtis, Amalia; Verhamme, Peter; Di Castelnuovo, Augusto; Cerletti, Chiara; Donati, Maria Benedetta; de Gaetano, Giovanni; Staessen, Jan A; Hoylaerts, Marc F; Iacoviello, Licia

Anti-therapeutic antibodies and their clinical impact in patients treated with the TNF antagonist adalimumab

抗治疗性抗体及其对接受 TNF 拮抗剂阿达木单抗治疗的患者的临床影响

Isabelle Cludts, Francesca Romana Spinelli, Francesca Morello, Jason Hockley, Guido Valesini, Meenu Wadhwa

Detection of neutralizing interleukin-17 antibodies in autoimmune polyendocrinopathy syndrome-1 (APS-1) patients using a novel non-cell based electrochemiluminescence assay

使用新型非细胞电化学发光分析法检测自身免疫性多发性内分泌腺病综合征-1(APS-1)患者中的中和白细胞介素-17 抗体

Isabelle Cludts, Anthony Meager, Robin Thorpe, Meenu Wadhwa