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

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: 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: 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

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

Impact of Formulation Choices on the Freeze-Drying of an Interleukin-6 Reference Material

配方选择对白细胞介素-6参考物质冻干的影响

Matejtschuk, Paul; Bird, Christopher; Ezeajughi, Ernest; MacLellan-Gibson, Kirsty; Wadhwa, Meenu

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021

世界卫生组织关于修订类似生物治疗产品评价指南的非正式磋商,线上会议,2021年6月30日至7月2日

Wadhwa, Meenu; Kang, Hye-Na; Thorpe, Robin; Knezevic, Ivana; Aprea, P; Bielsky, M-C; Ekman, N; Heim, H-K; Joung, J; Kurki, P; Lacana, E; Njue, C; Nkansah, E; Savkina, M; Thorpe, R; Yamaguchi, T; Wadhwa, M; Wang, J; Weise, M; Wolff-Holz, E

Therapeutic use of specific tumour necrosis factor inhibitors in inflammatory diseases including COVID-19

特定肿瘤坏死因子抑制剂在包括 COVID-19 在内的炎症性疾病中的治疗应用

Patel, Serena; Wadhwa, Meenu

Regulatory challenges with biosimilars: an update from 20 countries

生物类似药监管挑战:来自20个国家的最新情况

Kang, Hye-Na; Thorpe, Robin; Knezevic, Ivana; Casas Levano, Mary; Chilufya, Mumbi Bernice; Chirachanakul, Parichard; Chua, Hui Ming; Dalili, Dina; Foo, Freddie; Gao, Kai; Habahbeh, Suna; Hamel, Hugo; Kim, Gi Hyun; Perez Rodriguez, Violeta; Putri, Desi Eka; Rodgers, Jacqueline; Savkina, Maria; Semeniuk, Oleh; Srivastava, Shraddha; Tavares Neto, João; Wadhwa, Meenu; Yamaguchi, Teruhide

The first World Health Organization International Standard for infliximab products: A step towards maintaining harmonized biological activity.

世界卫生组织首个英夫利昔单抗产品国际标准:迈向维持生物活性一致性的一步

Metcalfe Clive, Dougall Thomas, Bird Chris, Rigsby Peter, Behr-Gross Marie-Emmanuelle, Wadhwa Meenu, Study Participants Of The