腺相关病毒
质量(理念)
良好制造规范
遗传增强
关键质量属性
过程(计算)
产品(数学)
计算生物学
设计质量
翻译(生物学)
计算机科学
生物
基因
医学
新产品开发
生物技术
载体(分子生物学)
遗传学
业务
数学
信使核糖核酸
重组DNA
几何学
监管事务
营销
哲学
操作系统
认识论
标识
DOI:10.1002/biot.202000022
摘要
Abstract For adeno‐associated virus (AAV)‐based human gene therapy, challenges for the translation of promising research results to successful clinical development include optimization of vector design and manufacturing processes to ensure that vectors prepared for administration to human subjects have attributes consistent with safe and durable expression. This article briefly reviews quality control methods for routine testing and supplemental characterization of AAV vectors for investigational product development. The relationship of vector and manufacturing process design with product critical quality attributes is discussed.
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