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

Proceedings of the 15(th) European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals

第十五届欧洲生物制药免疫原性平台开放研讨会论文集

Tourdot, Sophie; Bloem, Karien; Champion, Lysie; De Groot, Anne S; Ducret, Axel; Garidel, Patrick; Grudzinska-Goebel, Joanna; Gutknecht, Michael; Hickling, Timothy; Horling, Frank; Ichetovkin, Marina; Johnson, Alison; Jyamubandi, Issa; Karle, Anette; Kromminga, Arno; Kurtulmus, Ebru Aydin; Loeff, Floris; Maillere, Bernard; Michaut, Lydia; Minelli, Francesca; Nielsen, Morten; Nayak, Vivek; Nelson, Robert; Pallardy, Marc; Pattyn, Sofie; Pedras-Vasconelos, Joao; Pepermans, Elise; Poyau, Alain; Reichel, Matthias; Rosenberg, Amy; Sauna, Zuben; Saxena, Manisha; Smith, Noel; Snoeck, Veerle; Thoo, Lester; Tovey, Michael; Verthelyi, Daniela; Wuttke, Rene; Yerly, Daniel; Kramer, Daniel

Immunogenicity risk assessment of peptide-related impurities identified in generic teriparatide products

对仿制特立帕肽产品中发现的肽相关杂质进行免疫原性风险评估

Mattei, Aimee E; Roberts, Brian J; Lelias, Sandra; Miah, Shah; Howard, Kristina E; Weaver, James L; Verthelyi, Daniela; Pang, Eric S; Edwards, Katie; De Groot, Anne S

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

Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals

第十四届欧洲生物制药免疫原性平台开放研讨会论文集

Tourdot, Sophie; Baltrunkonis, Daniel; Denies, Sofie; Devanarayan, Viswanath; Grudzinska-Goebel, Joanna; Kromminga, Arno; Lotz, Gregor P; Malherbe, Laurent; Michaut, Lydia; Weldingh, Karin N; Pedras-Vasconcelos, Joao A; Salazar-Fontana, Laura I; Spindeldreher, Sebastian; Sauna, Zuben; Snoeck, Veerle; Verthelyi, Daniela; Kramer, Daniel

Assessing the immunogenicity risk of salmon calcitonin peptide impurities using in silico and in vitro methods

利用计算机模拟和体外方法评估鲑鱼降钙素肽杂质的免疫原性风险

Roberts, Brian J; Mattei, Aimee E; Howard, Kristina E; Weaver, James L; Liu, Hao; Lelias, Sandra; Martin, William D; Verthelyi, Daniela; Pang, Eric; Edwards, Katie J; De Groot, Anne S

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

Abstract Number ‐ 254: Yield of CTA in Patients over 50 with Brain Hemorrhages at Sites Typical for Hypertension

摘要编号 254:CTA 在 50 岁以上高血压典型出血部位脑出血患者中的应用价值

Manangeeswaran, Mohanraj; Ireland, Derek D C; Verthelyi, Daniela; Abuelgasim, Nazik A; Mannem, Narmada; Ullmann, Dawn W; Schmidley, James W

Neonatal Zika virus infection causes transient perineuronal net degradation

新生儿寨卡病毒感染会导致短暂的神经元周围网状结构退化

Engel, Kaliroi; Lee, Ha-Na; Tewari, Bhanu P; Lewkowicz, Aaron P; Ireland, Derek D C; Manangeeswaran, Mohanraj; Verthelyi, Daniela

Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients

治疗性肽和蛋白质中先天免疫反应调节杂质(IIRMI)的检测:辅料的影响

Thacker, Seth G; Her, Cheng; Kelley-Baker, Logan; Ireland, Derek D C; Manangeeswaran, Mohanraj; Pang, Eric S; Verthelyi, Daniela