Quality Control Testing, Characterization and Critical Quality Attributes of Adeno‐Associated Virus Vectors Used for Human Gene Therapy,Biotechnology Journal

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Quality Control Testing, Characterization and Critical Quality Attributes of Adeno‐Associated Virus Vectors Used for Human Gene Therapy
Biotechnology Journal ( IF 3.2 ) Pub Date : 2020-11-04 , DOI: 10.1002/biot.202000022
J. Fraser Wright ₁

Affiliation

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.

中文翻译：

用于人类基因治疗的腺相关病毒载体的质量控制测试，表征和关键质量属性

对于基于腺相关病毒（AAV）的人类基因治疗，将有前途的研究成果转化为成功的临床开发所面临的挑战包括优化载体设计和生产工艺，以确保准备用于人类受试者的载体具有与安全和稳定相一致的属性。持久的表达。本文简要回顾了用于研究产品开发的AAV载体的常规测试和补充表征的质量控制方法。讨论了矢量和制造工艺设计与产品关键质量属性之间的关系。

更新日期：2021-01-08

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