Abstract：
The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 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 the ICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2022 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 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Mass Spectrometry and ICH M10. Part 1B covers the Regulatory Agencies\' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (LBA, Biomarkers/CDx and Cytometry) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 15 of Bioanalysis, issues 15 and 14 (2023), respectively.
摘要：
第16届生物分析近期问题研讨会（第16届WRIB）在亚特兰大举行，GA,美国2022年9月26日至30日代表制药/生物技术公司的1000多名专业人士，CRO,和多个监管机构召开会议，积极讨论生物分析的最新主题。第16届WRIB包括3个主要研讨会和7个专业研讨会，这些研讨会跨越了1周，以便详尽而彻底地涵盖生物分析中的所有主要问题。生物标志物，免疫原性,基因治疗,细胞疗法和疫苗。此外，关于ICHM10BMV最终指南的深入研讨会(重点是本指南培训，解释,采用和过渡)；质谱创新(专注于新技术，新颖的模式，和新颖的挑战）；流式细胞术生物分析（在生物分析实验室中排名第三的最常见/最重要的技术的兴起）是第16版的特色。和往年一样,WRIB继续聚集了广泛的国际，行业意见领袖和监管机构专家致力于小分子和大分子以及基因，细胞疗法和疫苗，以促进专注于提高质量的分享和讨论，提高监管合规性，并在生物分析问题上实现科学卓越。这份2022年白皮书涵盖了研讨会期间广泛讨论中提出的建议，旨在为生物分析界提供有关主题和问题的关键信息和实际解决方案。为了实现科学卓越的进步，提高质量和更好的监管合规性。由于它的长度，出于编辑原因，本全面白皮书的2022年版分为三个部分。本出版物（第1A部分）涵盖了有关质谱和ICHM10的建议。第1B部分涵盖监管机构对生物分析的投入，生物标志物,免疫原性,基因和细胞治疗和疫苗。第二部分(LBA，生物标志物/CDx和细胞计数)和第3部分(基因治疗，细胞疗法,疫苗和生物治疗免疫原性）发表在《生物分析》第15卷中，第15和14期(2023年)，分别。
