创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

生物样本活库建设管理规范及应用专家共识

Expert Consensus on the Construction, Management, and Application of Living Biobank

  • 摘要: 生物样本活库是支撑新药研发与精准医疗的核心基础设施,依托低温保存技术,长期存储具有生物活性的细胞、类器官、人源肿瘤异种移植模型(patient-derived xenograft, PDX)等实体样本及多维度数据,由湿库(实体样本)与干库(数据)共同构成。针对当前行业面临的技术标准不统一、伦理合规界定模糊、人类遗传资源管理与跨境合规机制有待完善等挑战,结合国内外法规与实践,系统梳理生物样本活库管理体系、伦理合规要求、核心技术包含条件重编程(conditionally reprogrammed,CR)细胞、类器官、PDX及创新型微型人源肿瘤移植模型(mini-patient-derived xenograft,MiniPDX)/肿瘤免疫快速体内药效测试平台(immuno-oncology fast in vivo efficacy test,IO-FIVE)的建立与保存规范及信息化管理方案,重点阐述其在新药研发全流程、抗肿瘤药早期临床开发及个性化精准医疗中的转化应用,旨在形成行业共识,为相关机构提供实操性指导,助力我国转化医学与精准医疗高质量发展。

     

    Abstract: Living biobanks, comprising both physical specimens(wet bank) and associated data(dry bank), serve as a cornerstone infrastructure for new drug development and precision medicine. Leveraging cryopreservation technologies, these biobanks enable longterm preservation of native biological properties including cells, organoids and patient-derived xenograft(PDX), and multidimensional data. Despite its critical role, this field faces persistent challenges, including inconsistent technical standards, ambiguous ethical compliance boundaries, and the need to improve governance for human genetic resources and cross-border compliance. In response, this expert consensus synthesizes current domestic and international regulations and best practices to establish a standardized framework encompassing four pillars:(1) living biobank management systems;(2) ethical compliance requirements;(3) establishment and cryopreservation protocols for core living models—including conditionally reprogrammed(CR) cells, organoids, PDX, and innovative platforms such as mini-patient-derived xenograft(MiniPDX) and immuno-oncology fast in vivo efficacy test(IO-FIVE); and(4) information management architecture, with further highlight of their transformative applications across such domains as the full spectrum of drug discovery and development, early-phase oncology clinical trials, and personalized precision medicine, aiming to form a consensus for the industry, providing actionable guidance for the high-quality advancement of translational medicine and precision therapeutics in China.

     

/

返回文章
返回