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首页> 外文期刊>Bioanalysis >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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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)

机译：2020白皮书在生物分析中最近的问题：疫苗测定验证，QPCR测定验证，QC用于Car-T流式细胞术，NAB测定和ELISPOT验证（第3部分 - 关于免疫原性测定策略，NAB测定，生物酸和FDA / EMA免疫原性 指导/指南，基因和细胞疗法和疫苗测定）

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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.
机译：关于生物分析的最近问题的第14（Th）讲习班（第14（第14（第14条））于2020年6月15日至29日举行了2020年6月15日至29日，该公司出席了1000多个来自药物/生物制药公司，生物技术公司，合同研究组织的代表和全球监管机构。 14（Th）涉及三个主要研讨会，七个专业研讨会，共同跨越11天，以便允许生物分析，生物标志物，免疫原性，基因治疗和疫苗的所有主要问题的详尽和全面覆盖。此外，综合疫苗测定轨道;增强的细胞测量曲线和更新的行业/监管机构在BMVMS通过LCMS对BMV共识的同意于2020年。如前几年，今年的恐惧继续采取广泛多样化的国际行业舆论领导者和监管机构专家在兼职的情况下工作。大量分子促进分享和讨论的重点是提高质量，增加法规遵从和实现生物分析问题的科学卓越。

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