VectorFlow: Scalable viral vector downstream processing for gene therapy production

VectorFlow：用于基因治疗生产的可扩展病毒载体下游处理

• 批准号: 104293
• 金额: $ 93.22万
• 依托单位: LABXERO LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=104293
• 关键词: VectorFlow; Scalable; viral; vector; downstream

"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."

“针对一系列疾病适应症的基因疗法的成功临床试验最近获得了商业用途的监管批准。病毒载体的商业供应因缺乏负担得起的大规模下游制造工艺而受到限制，这些工艺在与工艺相关的杂质、样品/效力损失和可扩展性方面存在一些缺点_**，**_加工损失高达 90%。因此，改进 高效的基因治疗生产迫切需要可扩展的方法，保证病毒载体的产量和安全性，同时又不影响感染性/功能。VectorFlow 为基因治疗生产带来了创新的无化学品病毒载体提取/预过滤。这将克服关键的下游生物加工瓶颈，并在提高可行病毒载体的产量和质量方面发挥关键作用。 以可扩展、低成本的方式，有助于提高英国生产病毒载体的商业能力，以开发治疗人类疾病的基因疗法。作为下游生物加工技术的平台，VectorFlow 平台还可以扩展到其他先进治疗和生物制造应用，以最大限度地提高健康和生命科学领域的商业影响。”