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

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.