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

Evaluation of Anti-SARS-CoV-2 IgG Responses in a Clinical Study of a Biosimilar Candidate to Denosumab Using Singlicate Analysis

利用单次分析法评估地诺单抗生物类似药临床研究中抗SARS-CoV-2 IgG反应

Ribes, Sandra; Krivtsova, Natalia; Schelcher, Celine; Villalba-Izquierdo, Ana; Reiss, Falko; Richter, Mandy; Reisinger, Katrin; Poetzl, Johann

The changes necessary in the assessment of immunogenicity for the development of Biosimilars

生物类似药研发过程中免疫原性评估所需进行的改变

Poetzl, Johann

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

Simultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS.

利用混合 LBA-LC-MS/MS 同时对 IgG1 生物治疗药物的抗药抗体进行同型分型和半定量分析

Schalk Frank B, Guerrieri Davide, Poetzl Johann, van de Merbel Nico C

Introducing the Biosimilar Paradigm to Neurology: The Totality of Evidence for the First Biosimilar Natalizumab

将生物类似药模式引入神经病学领域:首个生物类似药那他珠单抗的全部证据

Selmaj, Krzysztof; Roth, Karsten; Höfler, Josef; Vitzithum, Klaus; Derlacz, Rafał; von Richter, Oliver; Hornuss, Cyrill; Poetzl, Johann; Singer, Barry; Jacobs, Laura

Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile

纳他珠单抗生物类似药与其参考药物的免疫原性比较评估:匹配的免疫原性谱

Chamberlain, Paul; Hemmer, Bernhard; Höfler, Josef; Wessels, Hendrik; von Richter, Oliver; Hornuss, Cyrill; Poetzl, Johann; Roth, Karsten

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

Telepathological evaluation of paediatric histological specimens in support of a hospital in Tanzania

为坦桑尼亚一家医院提供儿科组织学标本的远程病理评估

Voelker, Hans-Ullrich; Poetzl, Laura; Strehl, Annette; Mueller-Hermelink, Hans-Konrad; Stuefe, Ansgar; Stauch, Gerhard

Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study

GP2015(一种依那西普生物类似药)与参考药物依那西普在治疗中重度类风湿性关节炎患者中的疗效、安全性和免疫原性比较:来自比较性 III 期、随机、双盲 EQUIRA 研究的 24 周结果

Matucci-Cerinic, Marco; Allanore, Yannick; Kavanaugh, Arthur; Buch, Maya H; Schulze-Koops, Hendrik; Kucharz, Eugeniusz J; Woehling, Heike; Babic, Goran; Poetzl, Johann; Davis, Adanna; Schwebig, Arnd