Hersey Sarah, Keller Steve, Mathews Joel, King Lindsay, Bandukwala Abbas, Berisha Flora, Birchler Mary, Bower Joe, Clausen Valerie, Duarte Jose, Garofolo Fabio, Hopper Shirley, Kar Sumit, Mabrouk Omar, Marshall Jean-Claude, McGuire Kristina, Naughton Michael, Saito Yoshiro, Schuhmann Imelda, Sperinde Gizette, Teixeira Priscila, Vitaliti Alessandra, Wang Yow-Ming, Wnek Richard, Zhang Yan, Spitz Sue, Decman Vilma, Eck Steven, Estevam Jose, Goihberg Polina, Alcaide Enrique Gómez, Gonneau Christèle, Hedrick Michael Nathan, Hopkins Gregory, Junker Fabian, Nuti Sandra, Sommer Ulrike, Standifer Nathan, Stevens Chad, Stevens Erin, Hendricks Carrie, Wadhwa Meenu, Torri Albert, Ma Mark, Harris Shannon, Kumar Seema, Partridge Michael A, Caiazzo Teresa, Chilewski Shannon, Cludts Isabelle, Coble Kelly, Gorovits Boris, Grimaldi Christine, Jordan Gregor, Kamerud John, Leary Beth, Liang Meina, Lim Hanjo, Mayer Andrew, O'Connor Ellen, Palackal Nisha, Poetzl Johann, Prior Sandra, Abhari Mohsen Rajabi, Savoie Natasha, Soo Catherine, Ware Mark, Wu Bonnie, Xu Yang, Yang Tong-Yuan, Zoghbi Jad
Bristol-Myers Squibb, Lawrenceville, NJ, USA.
AbbVie, South San Francisco, CA, USA.
Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17.
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included three Main Workshops and seven Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term "context of use" [COU]); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and critical reagent and positive control generation were the special features of the 15th edition. This 2021 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry. Part 1A (Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC), Part 1B (Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 9 and 11 (2022), respectively.
第15届生物分析近期问题研讨会（第15届WRIB）于2021年9月27日至10月1日举行。即便在最后一刻从线下改为线上举办，仍有近900名来自制药和生物技术公司、合同研究组织（CRO）以及多个监管机构的专业人士踊跃参会，积极讨论生物分析领域当前最受关注的话题。第15届WRIB包括三个主研讨会和七个专业研讨会，历时一周，以便全面、深入地涵盖生物分析、生物标志物、免疫原性、基因治疗、细胞治疗和疫苗等所有重大问题。此外，关于生物标志物分析方法开发与验证（BAV）（重点是厘清因“使用背景”[COU]一词使用增多而产生的混淆）；蛋白质质谱分析（治疗性、生物标志物和转基因）；最新的细胞计数技术创新与验证；以及关键试剂和阳性对照生成的深入研讨会是第15届研讨会的特色。这份2021年白皮书涵盖了研讨会期间广泛讨论得出的建议，旨在为生物分析领域提供有关所涉主题和问题的关键信息及实际解决方案，以推动科学卓越性的进步、提高质量并更好地符合监管要求。由于篇幅原因，这份全面的2021年白皮书分为三个部分。本出版物（第2部分）涵盖了关于生物标志物的免疫稳定性检测（ISR）、液体活检、光谱细胞计数、吸入/口服及多特异性生物治疗药物、流式细胞术的准确性/定量下限（LLOQ）的建议。第1A部分（内源性化合物、小分子、复杂方法、大分子的规范质谱分析、小分子、即时检测[PoC]）、第1B部分（监管机构对生物分析、生物标志物、免疫原性、基因与细胞治疗及疫苗的意见）和第3部分（治疗性抗体/中和抗体、病毒载体伴随诊断、脱落分析；CRISPR/Cas9与嵌合抗原受体T细胞免疫原性；聚合酶链反应与疫苗分析性能；抗药物抗体分析的可比性与切点适用性）分别发表于《生物分析》第14卷第9期和第11期（2022年）。
