The emergence of cell gene therapy (CGT) as a safe and efficacious treatment for numerous severe inherited and acquired human diseases has led to growing interest and investment in new CGT products. The most successful of these have been autologous viral vector-based treatments. The development of viral vector manufacturing processes and ex vivo patient cell processing capabilities is a pressing issue in the advancement of autologous viral vector-based CGT treatments. In viral vector production, scale-up is a critical task due to the limited scalability of traditional laboratory systems and the demand for high volumes of viral vector manufactured in accordance with current good manufacturing practice. Ex vivo cell processing methods require optimisation and automation before they can be scaled out, and several other manufacturing challenges are prevalent such as high levels of raw material and process variability, difficulty characterising complex materials, and a lack of knowledge of critical process parameters and their effect on critical quality attributes of the viral vector and cell drug products. Multivariate data analysis (MVDA) has been leveraged successfully in a variety of applications in the chemical and biochemical industries, including for tasks such as bioprocess monitoring, identification of critical process parameters and assessment of process variability and comparability during process development, scale-up and technology transfer. Henceforth, MVDA is reviewed here as a suitable tool for tackling some of the challenges faced in the development of CGT manufacturing processes. A summary of some key CGT manufacturing challenges is provided along with a review of MVDA applications to mammalian and microbial processes, and an exploration of the potential benefits, requirements and pre-requisites of MVDA applications in the development of CGT manufacturing processes.

细胞基因疗法（CGT）作为一种安全有效的方法，可以治疗许多严重的遗传和获得性人类疾病，这引起了人们对新的CGT产品的兴趣和投资的增长。其中最成功的是基于自体病毒载体的治疗。病毒载体制造工艺和离体患者细胞加工能力的发展是基于自体病毒载体的CGT治疗进展中的紧迫问题。在病毒载体的生产中，由于传统实验室系统的可扩展性有限，并且需要根据当前的良好生产规范生产大量病毒载体，因此扩大规模是一项关键任务。离体电池加工方法需要先进行优化和自动化，然后才能进行横向扩展，并且还存在其他一些制造难题，例如高水平的原材料和工艺可变性，难以表征复杂的材料以及对关键工艺参数及其影响的认识不足病毒载体和细胞药物产品的关键质量属性。多元数据分析（MVDA）已在化学和生化行业的各种应用中得到成功利用，包括生物过程监控，关键过程参数的识别以及过程开发，放大和扩展过程中过程变异性和可比性评估等任务。技术转让。今后，此处对MVDA进行了评估，认为它是应对CGT制造工艺开发中所面临的一些挑战的合适工具。总结了一些关键的CGT制造挑战，并综述了MVDA在哺乳动物和微生物工艺中的应用，并探讨了MVDA在开发CGT制造工艺中的潜在好处，要求和前提条件。