细胞药物的标准及质量控制——细胞药物连载之四

The Standards and Quality Control of Cell Drug

细胞药物最终用于人体,必须建立相应的质量标准,进行质量控制。系统地贯彻到供者筛查、组织采集、细胞分离、培养、冻存、复苏、放行、运输、使用等全过程,确保产品的安全性、有效性和稳定性。近年来,我国逐渐改变了把细胞治疗作为第三类医疗技术管理的思路。一方面,已有第三类医疗技术取消行政审批;另一方面,又把除自体外的干细胞移植纳入药物管理,并建立了相应的质量标准和质量管理办法。

Cell drugs are eventually used in the human body,it is necessary to establish corresponding standards for quality control. To ensure the safety,effectiveness and stability of the product,the whole process of donor screening,tissue collection,cell separation,cell culture,cell cryopreservation,cell resuscitation,check out,transport and application must be systematically carried out. In recent years,China has gradually changed the management ideas of treating the cell therapy as the third level medical technology. On the one hand,the administrative examination and approval of already existing third level medical technology are currently cancelled.And on the other hand, stem cell transplantations are managed as drug except for autologous stem cell transplantation,and the corresponding standards and management method of quality have already been established.