Considering Cell Therapy Product “Good Manufacturing Practice” Status

Frontiers in Medicine

Patrick Bedford¹ 

关键词: cell therapy;    clinical trials;    regulatory;    manufacturing;    good manufacturing practices;    international perspective;   

DOI  :  10.3389/fmed.2018.00118

学科分类：医学（综合）

来源: Frontiers

【 摘 要 】

The promise of cell therapies is beginning to be recognized internationally. Cell therapy products (CTPs) are different from other drug products because many aim to be curative, and they are less comprehensively characterizable and more variable, sometimes being manufactured one lot at a time. They have complex mechanisms of action that remain incompletely understood. These unique features have led some regulators to take different approaches to cell therapy regulation in the form of special guidance for navigating regulatory frameworks that were originally intended for pharmaceutical drugs.

【 授权许可】

CC BY