2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3-Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3-Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
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DOI：
10.4155/bio-2021-0007
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发表时间：
2021-02-02
期刊：
影响因子：
1.8
通讯作者：
Xu, Yuanxin
中科院分区：
文献类型：
--
作者：
Corsaro, Bart;Yang, Tong-yuan;Xu, Yuanxin
第 14 届生物分析近期问题研讨会 (14(th) WRIB) 于 2020 年 6 月 15 日至 29 日以虚拟方式举行，来自世界各地的制药/生物制药公司、生物技术公司、合同研究组织和监管机构的 1000 多名代表出席了会议。第14届WRIB包括三个主要研讨会、七个专业研讨会，总共持续11天，以便详尽、彻底地涵盖生物分析、生物标志物、免疫原性、基因治疗和疫苗方面的所有重大问题。此外，全面的疫苗检测跟踪； 2020 年的特色是增强的细胞分析技术和更新的 LCMS 生物治疗药物 BMV 行业/监管机构共识。与往年一样，今年的 WRIB 继续聚集了广泛的国际行业意见领袖和监管机构专家，研究小分子和大分子，以促进专注于提高质量、提高监管合规性和实现生物分析问题科学卓越的分享和讨论。这份 2020 年白皮书包含了研讨会期间广泛讨论中提出的建议，旨在为全球生物分析界提供有关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、提高质量和更好地遵守法规。由于篇幅较长，出于编辑原因，2020 年版综合白皮书分为三个部分。本出版物（第 3 部分）涵盖了有关疫苗、基因/细胞治疗、NAb 协调和免疫原性的建议。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计数创新）和第 2B 部分（监管输入）分别发表在《生物分析》第 13 卷第 4 期和第 5 期（2020 年）中。
The 14(th) edition of the Workshop on Recent Issues in Bioanalysis (14(th) 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(th) 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.