Manufacturing of AcMNPV baculovirus vectors to enable gene therapy trials.
Manufacturing of AcMNPV baculovirus vectors to enable gene therapy trials.
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DOI：
10.1038/mtm.2015.50
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Wang S
中科院分区：
文献类型：
--
作者：
Kwang TW;Zeng X;Wang S
在过去的二十年中，杆状病毒已成为瞬时转基因表达的主要研究工具。尽管杆状病毒尚未在临床环境中直接用作基因治疗载体，但大量临床前研究表明，杆状病毒作为多种治疗应用（包括疫苗接种、组织工程和癌症治疗）的递送载体具有非常有前景的潜力。因此，人们对使用杆状病毒作为人类基因治疗载体越来越感兴趣，这导致了杆状病毒生物加工方法的进步。本综述概述了当前 AcMNPV 杆状病毒放大、浓缩、纯化和配制的方法，并强调了在启动基因治疗临床试验之前必须满足的关键监管要求。
Over the past two decades, baculoviruses have become workhorse research tools for transient transgene expression. Although they have not yet been used directly as a gene therapy vector in the clinical setting, numerous preclinical studies have suggested the highly promising potential of baculovirus as a delivery vector for a variety of therapeutic applications including vaccination, tissue engineering, and cancer treatment. As such, there is growing interest in using baculoviruses as human gene therapy vectors, which has led to advances in baculovirus bioprocessing methods. This review provides an overview of the current approaches for scaled-up amplification, concentration, purification, and formulation of AcMNPV baculoviruses, and highlights the key regulatory requirements that must be met before gene therapy clinical trials can be initiated.