Viral vectors are an emerging, exciting class of biologics whose application in vaccines, oncology, and gene therapy has grown exponentially in recent years. Following first regulatory approval, this class of therapeutics has been vigorously pursued to treat monogenic disorders including orphan diseases, entering hundreds of new products into pipelines. Viral vector manufacturing supporting clinical efforts has spurred the introduction of a broad swath of analytical techniques dedicated to assessing the diverse and evolving panel of Critical Quality Attributes (CQAs) of these products. Herein, we provide an overview of the current state of analytics enabling measurement of CQAs such as capsid and vector identities, product titer, transduction efficiency, impurity clearance etc. We highlight orthogonal methods and discuss the advantages and limitations of these techniques while evaluating their adaptation as process analytical technologies. Finally, we identify gaps and propose opportunities in enabling existing technologies for real-time monitoring from hardware, software, and data analysis viewpoints for technology development within viral vector biomanufacturing.

中文翻译：

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病毒载体制造过程分析技术的进步和机遇


病毒载体是一类新兴的、令人兴奋的生物制剂，近年来其在疫苗、肿瘤学和基因治疗中的应用呈指数级增长。在首次获得监管部门批准后，此类疗法一直被大力推广用于治疗包括孤儿疾病在内的单基因疾病，数百种新产品已进入研发阶段。支持临床工作的病毒载体制造刺激了广泛的分析技术的引入，这些技术致力于评估这些产品的多样化且不断发展的关键质量属性（CQA）。在此，我们概述了能够测量衣壳和载体身份、产物滴度、转导效率、杂质清除等 CQA 的分析现状。我们重点介绍正交方法，并讨论这些技术的优点和局限性，同时评估其适应性作为过程分析技术。最后，我们从硬件、软件和数据分析的角度找出现有技术的差距并提出机会，以实现病毒载体生物制造中技术开发的实时监控。