全球细胞治疗CMO/CDMO行业发展态势分析

Analysis on the Development Trend of CMO/CDMOS Industry in Global Cell Therapy

目的:通过全球细胞治疗CMO/CDMO行业发展现状和主要企业进行分析,揭示CMO/CDMO行业发展存在的质量评估问题,提出质量评估相关建议。方法:利用定量分析法和对比分析法进行分析,揭示全球免疫细胞和干细胞治疗产品开发现状和细胞治疗CMO/CDMO行业发展现状。结果:随着细胞治疗行业的发展,越来越多机构显示对细胞治疗CMO/CDMOS行业的兴趣,其通过创建、收购、投资等方式介入进来。目前已经确定提供合同细胞或基因治疗制造服务的48家公司。结论:细胞治疗行业发展导致了CMO/CDMOS合同制造协议的繁荣,鉴于细胞治疗的特殊性和复杂性,对细胞治疗CMO/CDMO质量评估也充满挑战。

Objective:Based on the analysis of the current situation and major enterprises of CMO/CDMOS industry in the world,this paper reveals the quality assessment problems existing in the development of CMO/CDMOS industry,and puts forward relevant suggestions for quality assessment.Methods:quantitative analysis and comparative analysis were used to reveal the development status of Immunotherapy and stem cell therapy products and CMO/CDMOS industry.Results:With the development of cell therapy industry,more and more institutions show their interest in cell therapy CMOS/cdmos industry,which is involved by means of creation,acquisition and investment.At present,48 companies have been identified to provide contract cell or gene therapy manufacturing services.Conclusion:The development of cell therapy industry has led to the prosperity of CMO/CDMOS contract manufacturing agreement.In view of the particularity and complexity of cell therapy,it is also full of challenges to the quality assessment of cell therapy.