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首页> 外文期刊>Bioanalysis >2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3-Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3-Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

机译：2019年白皮书在生物分析中最近的问题：FDA免疫原性指导，基因治疗，关键试剂，生物标志物和流式细胞术验证（第3部分 - 2019年FDA免疫原性指导，基因治疗生物分析挑战，批判试剂管理的策略，BioMarker测定验证， 流式细胞仪验证和CLSI H62）

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摘要

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1-5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies world-wide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 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 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers New Insights in Biomarker Assay Validation, Current & Effective Strategies for Critical Reagent Management, Flow Cytometry Validation in Drug Discovery & Development & CLSI H62, Interpretation of the 2019 FDA Immunogenicity Guidance and Gene Therapy Bioanalytical Challenges. Part 1 (Innovation in Small Molecules and Oligonucleotides & Mass Spectrometry Method Development Strategies for Large Molecule Bioanalysis) and Part 2 (Recommendations on the 2018 FDA BMV Guidance, 2019 ICHM10 BMV Draft Guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy) are published in volume 11 of Bioanalysis, issues 22 and 23 (2019), respectively.
机译：2019年第13次讲习班关于生物分析（WRIB）最近的问题，于2019年4月1日至5日在美国举行的新奥尔良，LA，举办了超过1000多个代表的药物/生物制药公司，生物技术公司，合同研究组织和监管机构的出席全世界。 WRIB再次为期5天，一周的事件 - 生物分析，生物标志物，免疫原性和基因治疗的全浸渍周。正如往常，它专门旨在促进分享，审查，讨论和同意解决最新利益问题的方法，包括涉及LCMS，杂种LBA / LCMS，基于LBA细胞的/流式细胞仪的小和大分子生物分析测定和QPCR方法。本文2019年白皮书包括从研讨会举行的广泛讨论中出现的建议，并旨在为生物分析社区提供关键信息和解决主题和问题的实用解决方案，以便能够实现科学卓越，提高质量和更好的监管遵守。由于其长度，2019年这份全面的白皮书被分为三个部分，因为编辑原因。本出版物（第3部分）涵盖了生物标志物测定验证，当前和有效策略的新见解，可关键试剂管理，药物发现中的流式细胞术验证和CLSI H62，解释2019年FDA免疫原性指导和生物分析挑战的基因治疗。第1部分（小分子的创新和大分子生物分析的小分子和寡核苷酸和质谱法发育策略）和第2部分（关于2018年FDA BMV指导的建议，2019 ICHM10 BMV指南指南和监管机构的生物分析，生物标志物，免疫原性和基因。疗法分别发表于生物分析的第11卷，问题22和23（2019）中公布。

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