Design, Transfer and Qualification of a Commercially-Scalable Process for Viral Vectors

病毒载体商业化工艺的设计、转移和鉴定

• 批准号: 104198
• 金额: $ 156.2万
• 依托单位: AUTOLUS 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=104198
• 关键词: Design; Transfer; Qualification; Commercially; Scalable

"Advanced Therapies have come of age. The spectacular clinical results demonstrated by novel gene-engineered T-cell therapies, with subsequent regulatory approvals in the US, have confirmed the commercial reality of a new class of therapeutics that offer real hope to patients who are bereft of effective treatment options. But behind this hope lies a deep concern that high cost-of-goods and problematical scalability will severely limit patient access to these therapies.A critical component of these therapies is a recombinant viral vector capable of effectively transducing the T-cells and enabling the expression of novel anti-tumour receptors. Unfortunately, the current technologies to manufacture these vectors at commercial scales are not fit for purpose. This project will combine leading academic expertise and the commercial imperative of a UK Biotech company to create innovative and scalable viral vector processes that will facilitate patient access to Advanced Therapies."

“先进的治疗方法已经成熟。新型基因工程t细胞疗法所展示的惊人临床结果，以及随后在美国获得的监管机构批准，证实了一类新型疗法的商业现实，为缺乏有效治疗选择的患者带来了真正的希望。但在这一希望的背后，人们深切关注的是，高昂的商品成本和有问题的可扩展性将严重限制患者获得这些疗法的机会。这些疗法的一个关键组成部分是重组病毒载体，能够有效地转导t细胞并使新的抗肿瘤受体表达。不幸的是，目前在商业规模上制造这些载体的技术并不适合这一目的。该项目将结合领先的学术专业知识和英国生物技术公司的商业需求，创造创新和可扩展的病毒载体流程，促进患者获得先进的治疗方法。”