医疗机构细胞产品制备中心现状和发展策略

Current status and development strategies of cellular products manufacturing center in medical institutions

我国细胞治疗产品主要依托医疗机构或标准化制备机构进行生产,与标准化制备机构相比,医疗机构细胞制备中心具有样本来源丰富、治疗方案灵活、距离和时效等优势,但同时也存在产量小、洁净车间建设管理经验不足、经费支撑有限等问题。基于现状,该文提出多模式协作、GMP专业辅助、提高科研成果转化率等发展策略,随着生产设备/材料国产化、成果转化等利好政策落地,医疗机构细胞产品制备中心将成为临床前瞻性、探索性研究及细胞产品制备的重要依托,丰富重大及难治性疾病的治疗方法。

Celluar therapy products in China are mainly produced by medical institutions or standardized manufacturing companies. Compared with standardized manufacturing companies, celluar manufacturing centers in medical institutions have the advantages of abundant sample sources, flexible treatment schedule,distance and timeliness. However, there are also some problems such as small output, lack of experience in construction and management of clean workshops, and limited financial support. Based on the current situation, this paper proposes development strategies such as multi-mode collaboration,GMP professional assistance, and improvement of the transformation rate of scientific research results.With the development of domestic production equipments and materials, and the implementation of favorable policies encouraging achievement transformation, the celluar manufacturing center of medical institutions will become an important support for clinical prospective and exploratory research and celluar product manufacturing, and enrich the treatment methods for major and refractory diseases.