VectorFlow: Scalable viral vector downstream processing for gene therapy production

“基因疗法在一系列疾病适应症中的成功临床试验导致了最近的商业用途监管批准。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，所述下游制造工艺在工艺相关杂质、样品/效力损失和可扩展性方面具有若干缺点，其中加工损失高达90%。因此，高效的基因治疗生产迫切需要改进的可扩展方法，以保证病毒载体的产量和安全性，而不影响感染性/功能性。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。这将克服一个关键的下游生物加工瓶颈，并在以可扩展的低成本方式提高可行病毒载体的产量和质量方面发挥关键作用，有助于提高英国生产用于开发治疗人类疾病的基因疗法的病毒载体的商业能力。作为下游生物处理技术平台，VectorFlow平台还可以扩展到其他先进的治疗和生物制造应用，以最大限度地提高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."