嵌合抗原受体T细胞免疫治疗产品扩大产能过程中的风险因素分析

Analysis of Risk Factors in the Manufacturing Scale-up of Chimeric Antigen Receptor T Cell Therapeutic Products

嵌合抗原受体T细胞免疫治疗(CAR-T)产品在多种血液肿瘤治疗中显示了非常好的临床效果。近年来,我国CAR-T产品研究也呈现蓬勃发展的态势。随着企业品种的适应证不断增加及市场需求的增加,部分生产企业产能需要进一步扩大。文章通过梳理CAR-T产品在扩大产能过程中厂房布局、设备、公用系统、人员及过程控制等方面的影响,分析各要素可能存在的风险,为该类产品质量的持续改进和监管机构的监管提供参考。

Chimeric antigen receptor T cell immune-therapy(CAR-T)products have shown very good clinical effects in a variety of blood tumors.In recent years,research on CAR-T products in China has also exhibited a booming development trend.As the varieties of CAR-T products and their indications continue to increase and market demand rises,the production capacity of some manufacturers needs to be further expanded.This paper analyzes the possible risks of various factors by combing through the impacts of factory layout,equipment,public system,personnel,and process control during the expansion of CAR-T product production capacity,providing a reference for the continuous improvement of the quality of such products and the supervision of regulatory agencies.