Abstract: Cell and gene therapy (CGT) in China has evolved into a parallel framework encompassing approved commercial products, registered clinical trials, investigator-initiated trials, hospital GMP platforms, and preparations developed within hospitals. Because CGT relies on living cellular products, quality risks extend across the entire process from collection and manufacturing to storage, infusion, and follow-up. International practice demonstrates that transfusion medicine contributes meaningfully to cellular collection, identity verification, cold chain management, clinical release, and adverse event monitoring. Within Chinese hospitals, a stable quality linkage mechanism between cell manufacturing and clinical administration is currently lacking, and institutional responsibility for in-hospital CGT oversight remains undefined. Transfusion medicine departments possess mature expertise in cell preservation, apheresis technology, cold chain management, and transfusion risk control—capabilities that align closely with in-hospital CGT quality management requirements. This article proposes an in-hospital CGT quality control framework supported by transfusion medicine departments, offering a reference model for the standardized implementation of somatic cell therapy, stem cell therapy, and exosome therapies.

Key words: Cell and gene therapy, Somatic cell therapy, Stem cell, Transfusion medicine, Quality control