病毒载体
计算机科学
可扩展性
过程(计算)
良好制造规范
质量(理念)
设计质量
计算生物学
下游(制造业)
生化工程
生物技术
生物
工程类
重组DNA
基因
运营管理
监管事务
哲学
操作系统
认识论
数据库
生物化学
作者
Ruina Shi,Shenghua Jia,Huwei Liu,Honggang Nie
标识
DOI:10.1002/jssc.202100937
摘要
Lentiviral vectors have been proven to be a powerful tool in gene therapies that includes the ability to perform long‐term gene editing in both dividing and non‐dividing cells. In order to meet the rising demand for clinical‐grade lentiviral vectors for future clinical trials and requirements by regulatory agencies, new methods and technologies were developed, including the rapid optimization of production and purification processes. However, gaps still exist in achieving ideal yields and recovery rates in large‐scale manufacturing process steps. The downstream purification process is a critical step required to obtain a sufficient quantity and high‐quality lentiviral vectors products, which is challenged by the low stability of the lentiviral vector particles and large production volumes associated with the manufacturing process. This review summarizes the most recent and promising technologies and enhancements used in the large‐scale purification process step of lentiviral vector manufacturing and aims to provide a significant contribution towards the achievement of providing sufficient quantity and quality of lentiviral vectors in scalable processes.
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