From blood banking to advanced therapeutics: reframing transfusion medicine in the era of cell and gene therapy in China
DOI:
https://doi.org/10.46701/jbbt260501Keywords:
cell and gene therapy; transfusion medicine; hospital-based governance; clinical release; advanced therapeutics; ChinaAbstract
Cell and gene therapy (CGT) is rapidly reshaping the therapeutic landscape in China, where approved commercial products, registered clinical trials, investigator-initiated studies (IITs), and hospital-based translational platforms are developing in parallel. This pattern is especially pronounced in cellular therapeutics, including immune effector cell therapies, stem cell-based products, and selected cell-derived therapeutics. As living and highly individualized therapeutic products, these interventions require not only robust manufacturing processes but also safe and coordinated implementation within hospitals. A critical challenge lies in the hospital-based interval between manufacturing release and bedside administration, encompassing product receipt, chain of identity control, chain of custody maintenance, storage oversight, clinical release, and post-infusion surveillance. In this context, transfusion medicine should be reconsidered beyond its conventional function in blood banking. Transfusion medicine, as a hospital-based discipline with well-established expertise in apheresis, product identification, cold-chain management, traceability, and transfusion safety, possesses a competency profile that aligns closely with the unmet governance requirements of cellular therapy programs. This review examines the Chinese institutional context and contends that transfusion medicine can function as a coordinating governance interface between manufacturing and clinical application. Reframing transfusion medicine in this way may help strengthen hospital-based therapeutic stewardship, improve implementation safety, and support the sustainable development of advanced cellular therapies in China.
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