16 个 GCC 封闭式论坛：ICH M10 实施；NGS、qPCR/dPCR、流式细胞术验证；组织生物标志物；IS 反应；免疫原性协调；生物分析行业现状。
16 GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.
机构信息
Alturas Analytics, Moscow, Idaho, USA.
BioAgilytix, Durham, North Carolina, USA.
出版信息
Bioanalysis. 2024 Jun 2;16(11):505-517. doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12.
Abstract
The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.
摘要
第十六届海湾合作委员会封闭论坛于 2023 年 6 月 23 日在美国佛罗里达州奥兰多市举行。国际生物分析合同研究组织的代表出席了会议，以便讨论生物分析方面的具体科学和监管问题。会议讨论的问题包括：IS 应答、流式细胞术、生物分析行业的变化、下一代测序检测、组织生物标志物检测、dPCR 验证、免疫原性协调和 ICH M10 实施。本文收录了这些主题讨论的结论和共识。
相似文献
1
16 GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.16 个 GCC 封闭式论坛：ICH M10 实施；NGS、qPCR/dPCR、流式细胞术验证；组织生物标志物；IS 反应；免疫原性协调；生物分析行业现状。
Bioanalysis. 2024 Jun 2;16(11):505-517. doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12.
2
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 ( - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).2020 年生物分析近期问题白皮书：疫苗分析验证、qPCR 分析验证、CAR-T 流式细胞术 QC、中和抗体分析一致性和 ELISpot 验证（免疫原性分析策略、中和抗体分析、生物类似药和 FDA/EMA 免疫原性指导/指南、基因和细胞治疗及疫苗分析的建议）。
Bioanalysis. 2021 Mar;13(6):415-463. doi: 10.4155/bio-2021-0007. Epub 2021 Feb 3.
3
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).2022 年生物分析近期问题白皮书：ICH M10 BMV 指南和全球协调；混合测定法；寡核苷酸和 ADC；非液相和稀有基质；监管意见（-关于质谱、色谱和样品制备的建议，新型技术，新型模式和新的挑战，ICH M10 BMV 指南和全球协调-监管机构对监管生物分析/ BMV、生物标志物/ CDx/ BAV、免疫原性、基因和细胞治疗以及疫苗的输入）。
Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31.
4
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).《2019年生物分析近期问题白皮书：美国食品药品监督管理局免疫原性指南、基因治疗、关键试剂、生物标志物及流式细胞术验证（第3部分 - 关于2019年美国食品药品监督管理局免疫原性指南、基因治疗生物分析挑战、关键试剂管理策略、生物标志物检测验证、流式细胞术验证及临床和实验室标准协会H62的建议）》
Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10.
5
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.海湾合作委员会向国际人用药品注册技术协调会提交的关于《2019年国际人用药品注册技术协调会M10生物分析方法验证指南草案》的综合反馈意见。
Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30.
6
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).2019年生物分析近期问题白皮书：美国食品药品监督管理局生物分析方法验证指南、国际人用药品注册技术协调会M10生物分析方法验证指南及监管意见（ - 关于2018年美国食品药品监督管理局生物分析方法验证指南、2019年国际人用药品注册技术协调会M10生物分析方法验证草案指南以及监管机构对生物分析、生物标志物和免疫原性的意见的建议）
Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9.
7
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.2022 年生物分析近期问题白皮书：酶法分析验证、主要终点的 BAV、疫苗功能分析、组织中的细胞仪、稀有基质中的 LBA、复杂的中和抗体分析、光谱细胞仪、内源性分析物、细胞外囊泡 - 生物标志物/CDx 建议、流式细胞术、配体结合分析开发和验证；新兴技术；关键试剂的深度表征。
Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16.
8
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).2023 年生物分析新问题白皮书：ADA 分析的 ISR、dPCR 对 qPCR 的兴起、疫苗分析的国际参考标准、抗 AAV TAb 给药后评估、NanoString 验证、作为金标准的 ELISpot - 基因治疗、细胞治疗、疫苗免疫原性和技术建议；生物治疗药物免疫原性和风险评估；ADA/NAb 分析/报告的协调统一）。
Bioanalysis. 2024 Apr;16(7):77-119. doi: 10.4155/bio-2024-0024. Epub 2024 Feb 22.
9
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.第12届海湾合作委员会封闭论坛：关键试剂；寡核苷酸；辅酶A；方法转移；高分辨率质谱；流式细胞术；监管结果；稳定性和免疫原性。
Bioanalysis. 2019 Jun;11(12):1129-1138. doi: 10.4155/bio-2019-0131. Epub 2019 Jul 19.
10
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).2022 年生物分析最新问题白皮书：FDA 关于处方药标签中免疫原性信息的指南草案、LNP 和病毒载体治疗学/疫苗免疫原性、延长效应、ADA 亲和力、基于风险的方法、下一代测序、qPCR、数字 PCR 检测（-基因治疗、细胞治疗、疫苗免疫原性和技术的建议；生物治疗药物和新型疗法的免疫原性和风险评估；中和抗体检测的综合方法）。
Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1.
引用本文的文献
1
Recommendations on biomarker assay validation (BAV) in tissues by GCC.全球癌症组织（GCC）关于组织中生物标志物检测验证（BAV）的建议。
Bioanalysis. 2025 Apr;17(7):429-438. doi: 10.1080/17576180.2025.2471243. Epub 2025 Apr 18.
本文引用的文献
1
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).2023 年生物分析新问题白皮书：ADA 分析的 ISR、dPCR 对 qPCR 的兴起、疫苗分析的国际参考标准、抗 AAV TAb 给药后评估、NanoString 验证、作为金标准的 ELISpot - 基因治疗、细胞治疗、疫苗免疫原性和技术建议；生物治疗药物免疫原性和风险评估；ADA/NAb 分析/报告的协调统一）。
Bioanalysis. 2024 Apr;16(7):77-119. doi: 10.4155/bio-2024-0024. Epub 2024 Feb 22.
2
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).2022 年生物分析最新问题白皮书：FDA 关于处方药标签中免疫原性信息的指南草案、LNP 和病毒载体治疗学/疫苗免疫原性、延长效应、ADA 亲和力、基于风险的方法、下一代测序、qPCR、数字 PCR 检测（-基因治疗、细胞治疗、疫苗免疫原性和技术的建议；生物治疗药物和新型疗法的免疫原性和风险评估；中和抗体检测的综合方法）。
Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1.
3
Neutralizing Antibody Validation Testing and Reporting Harmonization.中和抗体验证检测和报告的协调统一。
AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5.
4
Anti-drug Antibody Sample Testing and Reporting Harmonization.抗药物抗体样本检测和报告的协调统一。
AAPS J. 2022 Oct 28;24(6):113. doi: 10.1208/s12248-022-00762-6.
5
Recommendations on qPCR/ddPCR assay validation by GCC.GCC 关于 qPCR/ddPCR assay 验证的建议。
Bioanalysis. 2022 Jun;14(12):853-863. doi: 10.4155/bio-2022-0109. Epub 2022 Jun 15.
6
Anti-drug Antibody Validation Testing and Reporting Harmonization.抗药物抗体验证测试和报告的协调统一。
AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y.
7
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.关于生物分析用参照标准证书内容和管理的建议——GCC 准则
Bioanalysis. 2021 Apr;13(8):609-619. doi: 10.4155/bio-2021-0046. Epub 2021 Apr 13.
8
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.海湾合作委员会向国际人用药品注册技术协调会提交的关于《2019年国际人用药品注册技术协调会M10生物分析方法验证指南草案》的综合反馈意见。
Bioanalysis. 2019 Sep;11(18s):1-228. doi: 10.4155/bio-2019-0207. Epub 2019 Sep 30.
9
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.第12届海湾合作委员会封闭论坛：关键试剂；寡核苷酸；辅酶A；方法转移；高分辨率质谱；流式细胞术；监管结果；稳定性和免疫原性。
Bioanalysis. 2019 Jun;11(12):1129-1138. doi: 10.4155/bio-2019-0131. Epub 2019 Jul 19.
10
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.海湾合作委员会生物分析小组对药物研发中生物标志物商业LBA试剂盒分类的建议。
Bioanalysis. 2019 Apr;11(7):645-653. doi: 10.4155/bio-2019-0072. Epub 2019 Apr 17.
Zotero 插件