VectorFlow: Scalable viral vector downstream processing for gene therapy production

针对一系列疾病适应症的基因疗法的成功临床试验最近导致了监管部门批准将其用于商业用途。病毒载体的商业供应受到缺乏负担得起的大规模下游制造工艺的限制，这些工艺在与工艺相关的杂质、样品/效力损失和可伸缩性_**、**_方面存在几个缺陷，加工损失高达90%。因此，高效的基因治疗生产迫切需要改进的可扩展方法，既保证病毒载体的产量和安全性，又不影响感染性/功能性。VectorFlow将创新的无化学病毒载体提取/预过滤引入基因治疗生产。这将克服下游生物处理的一个关键瓶颈，并在以可扩展、低成本的方式提高可行病毒载体的产量和质量方面发挥关键作用，有助于提高英国制造病毒载体的商业能力，用于开发治疗人类疾病的基因疗法。作为生物处理技术下游的平台，VectorFlow平台还可以扩展到其他先进的治疗和生物制造应用，以最大限度地扩大健康和生命科学领域的商业影响。“

"Successful clinical trials of gene-therapies for a range of disease-indications have led to recent regulatory approvals for commercial use. Commercial-supply of viral vectors is limited by lack of affordable large-scale downstream manufacturing processes,which have several drawbacks in terms of process-related impurities, sample/potency loss and scalability_**,**_ with processing losses as high as 90%. Hence, improved scalable methods that guarantee viral vector yield and safety without compromising infectivity/functionality are urgently needed for high-efficiency gene-therapy manufacturing.VectorFlow brings innovative chemical-free viral-vector extraction/pre-filtration to gene-therapy production. This will overcome a key downstream bioprocessing bottleneck and play a pivotal role in increasing the yield and quality of viable viral-vectors in a scalable, low-cost manner, helping to increase the UK's commercial capacity to manufacture viral-vectors for the development of gene therapies to treat human disease. As a platform downstream bioprocessing technology, the VectorFlow platform can also be expanded to other advanced therapy and biomanufacturing applications to maximise commercial impact within the health and life sciences sector."