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

IQ Survey Results on Current Industry Practices: Part 2-Quantitative Evaluations of Immunogenicity Assessment

IQ调查结果:当前行业实践——第二部分:免疫原性评估的定量评价

Richards, Susan; Winzenborg, Insa; Luedtke, Doreen; Niu, Tao; Hamuro, Lora; Kowalski, Karey; Leu, Jocelyn H; Yang, Jianning; Ganti, Vaishnavi; Bhattacharya, Indranil; Gueorguieva, Ivelina; Mostafa, Nael; Grimaldi, Christine; Wu, Benjamin

IQ Survey Results on Current Industry Practices-Part 1: Immunogenicity Risk Assessment

IQ调查结果:当前行业实践——第一部分:免疫原性风险评估

Grimaldi, Christine; Richards, Susan; Baltrukonis, Daniel; Sims Belouski, Shelley; Coble, Kelly; Dholakiya, Sanjay L; Grudzinska-Goebel, Joanna; Kolaitis, Gerry; Leu, Jocelyn H; Luo, Linlin; Lowe, Stephen; Niu, Tao; Toft-Hansen, Henrik; Yang, Jianning; Wu, Benjamin

Host Cell Protein Clinical Safety Risk Assessment-An Updated Industry Review

宿主细胞蛋白临床安全风险评估——最新行业综述

Coye, Lisette; Jones, Marisa A; Gaza-Bulseco, Georgeen; Chitikila, Carmelata; Clavier, Severine; Fougeron, Delphine; Grimaldi, Christine; Hurkmans, Karen; Hutchinson, Richard; Kellogg, Brenda; Liu, Xinrong; Palackal, Nisha; Tank, Mahima; Valax, Pascal; Waerner, Thomas; Wang, Fengqiang; Zhang, Ying; Zhao, Yiwei; Sloan, Sapphire; de Zafra, Christina Zuch

2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and

2025 年生物分析最新问题白皮书:生物标志物校准品和稳定性;核素标记免疫球蛋白结合免疫球蛋白 (NULISA) 的评估;神经丝和自身抗体生物标志物检测;消除 IgM 干扰;酶联免疫斑点 (ELISpot) 和荧光斑点 (FluoroSpot) 最佳实践;模块化高清流式细胞术;单细胞分析成像流式细胞术(第二部分 A - 关于生物标志物发现、开发、验证和监管审批、配体结合分析 (LBA) 和基于细胞的分析 (CBA) 的建议;第二部分 B - 监管机构对生物标志物、体外诊断/伴随诊断 (IVD/CDx) 的意见)

Hersey, Sarah; McGuire, Kristina; Kholmanskikh, Olga; Bivi, Nicoletta; Bandukwala, Abbas; Gong, Binsheng; Irwin, Chad; Ray, Soma; Gunsior, Michele; Avanesov, Andrei; Baker, Brian; Bond, Sarah; Braun, Alexander; Buoninfante, Alessandra; Dessy, Francis; Fang, Xiaodong; Garofolo, Fabio; Gomme, Emily; Hays, Amanda; King, Lindsay; Mayer, Christian; McGregor, Jessica; McHenry, Melis; Nowocin, Anna; Rubel, Carrie; Sanderink, Gerard; Scott, Bradley; Scully, Ingrid; Seyda, Agnes; Stoop, Jeroen; Tang, Huaping; Neto, Joao Tavares; Walravens, Karl; Wang, Kai; Wassmer, Sarah; Xiao, Wenming; Zhu, Liang; Zoghbi, Jad; Brockus, Catherine; Petit-Frere, Corinne; Coble, Kelly; Fischer, Sally; Yearwood, Graham; Cao, Liching; Dysinger, Mark; Grimaldi, Christine; Jiang, Yong; Joyce, Alison; Kerridge, Claire; Lu, Kun; McCush, Fred; Nolan, Katrina; Connor, Ellen O'; Palmer, Rachel; Reese, Kimberly; Stubenrauch, Kay-Gunnar; Verch, Thorsten; Beaver, Christopher; Mendez, Luis; Decman, Vilma; Bhavaraju, Kamala; Huleatt, James; Trampont, Paul C; Eck, Steven; Goihberg, Polina; Alcaide, Enrique Gomez; Hedrick, Michael Nathan; Jalah, Rashmi; McGrath, Shannon; Ogorman, William; Prior, Sandra; Sehra, Sarita; Shaik, Saleem; Standifer, Nathan; Stevens, Chad; Stevens, Erin; Sun, Yongliang Steve

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: 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

Trends in industrialization of biotherapeutics: a survey of product characteristics of 89 antibody-based biotherapeutics

生物治疗药物产业化趋势:89种抗体生物治疗药物产品特性调查

Martin, Kyle P; Grimaldi, Christine; Grempler, Rolf; Hansel, Steven; Kumar, Sandeep

Safety, pharmacokinetics and pharmacodynamics of BI 655064 in phase 1 clinical trials in healthy Chinese and Japanese subjects

在健康中国和日本受试者中开展的 BI 655064 I 期临床试验的安全性、药代动力学和药效学研究

Tsuda, Yasuhiro; Grimaldi, Christine; Huang, Fenglei; Benediktus, Ewald; Yagi, Nobutaka; Padula, Steven J; Jang, In-Jin; Steffgen, Jürgen

Retrospective analysis of model-based predictivity of human pharmacokinetics for anti-IL-36R monoclonal antibody MAB92 using a rat anti-mouse IL-36R monoclonal antibody and RNA expression data (FANTOM5).

使用大鼠抗小鼠 IL-36R 单克隆抗体和 RNA 表达数据 (FANTOM5) 对抗 IL-36R 单克隆抗体 MAB92 的人体药代动力学进行基于模型的预测的回顾性分析

Ahlberg Jennifer, Giragossian Craig, Li Hua, Myzithras Maria, Raymond Ernie, Caviness Gary, Grimaldi Christine, Brown Su-Ellen, Perez Rocio, Yang Danlin, Kroe-Barrett Rachel, Joseph David, Pamulapati Chandrasena, Coble Kelly, Ruus Peter, Woska Joseph R, Ganesan Rajkumar, Hansel Steven, Mbow M Lamine