全球细胞治疗CMO/CDMO行业发展态势分析

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。

Antibody-Drug Conjugates (ADCs): Navigating Four Pillars of Safety, Development, Supply Chain and Manufacturing Excellence

Antibody-drug conjugates (ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and many under development, ADCs are poised to revolutionize therapeutics. This paper examines the complexities of ADC production, emphasizing the importance of process characterization and the pivotal role of supply chain characteristics, safety requirements, and Contract Manufacturing Organizations (CMOs) with proficiency. The swift transition of antibody-drug conjugate (ADC) programs from early to advanced clinical stages underscores the urgency for quick and efficient commercial launch preparation. This article delves into strategies to hasten commercial readiness, supply chain strategy, the significance of partnering with adept contract development and manufacturing organizations (CDMOs), and the challenges of ADC production.

我国离岸医药外包服务的发展现状与建议

经济全球化的发展伴随着国际分工的细化,作为知识流程外包形式之一的离岸医药外包,已经成为全球药物研发价值链中不可或缺的重要环节。我国离岸医药外包起步晚、发展快,承接业务范围广,业务格局自有特色,行业扶持政策不断优化。在快速发展过程中存在服务能力不足、产业结构待调整、成本上升削弱、国际竞争力和配套政策不完善的问题。促进我国离岸医药外包行业发展,需要从提升行业标准、调整产业结构、财税、金融、贸易便利化和完善配套政策等方面,努力构建离岸医药外包政策支持体系。