GlaxoSmithKline, Rockville, MD, USA.
Janssen R&D, Spring House, PA, USA.
Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3.
The 14 edition of the Workshop on Recent Issues in Bioanalysis (14 WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14 WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global 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 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity). Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation) and Part 2B (Regulatory Input) are published in volume 13 of Bioanalysis, issues 4 and 5 (2020), respectively.
第 14 届生物分析最新问题研讨会（14 WRIB）于 2020 年 6 月 15 日至 29 日以虚拟方式举行，来自全球制药/生物制药公司、生物技术公司、合同研究组织和监管机构的代表超过 1000 人参加。第 14 届 WRIB 包括三个主要研讨会，七个专门研讨会，共涵盖 11 天，以便全面彻底地涵盖生物分析、生物标志物、免疫原性、基因治疗和疫苗所有主要问题。此外，2020 年还特别设立了一个全面的疫苗分析方法学轨道、一个增强的细胞分析轨道，以及对基于 LCMS 的生物疗法 BMV 的行业/监管机构的最新共识。与往年一样，今年的 WRIB 继续汇集了广泛的国际行业意见领袖和监管机构专家，他们致力于小分子和大分子，以促进分享和讨论，重点是提高质量、提高监管合规性和在生物分析问题上取得科学卓越。本白皮书涵盖了研讨会期间广泛讨论产生的建议，旨在为全球生物分析界提供关于所讨论主题和问题的关键信息和实用解决方案，努力推动科学卓越、提高质量和更好的监管合规性的发展。由于篇幅较长，出于编辑原因，2020 年版的这份全面白皮书分为三部分。本出版物（第 3 部分）涵盖了疫苗、基因/细胞治疗、中和抗体（NAb）协调和免疫原性方面的建议。第 1 部分（小分子创新、混合 LBA/LCMS 和监管生物分析）、第 2A 部分（BAV、PK LBA、流式细胞术验证和细胞术创新）和第 2B 部分（监管意见）分别发表在第 13 卷第 4 期和第 5 期（2020 年）的 Bioanalysis 杂志上。
