Cell2Sell: commercial scale next generation platform for allogeneic stem cell production

Cell2Sell：商业规模的下一代同种异体干细胞生产平台

• 批准号: 103239
• 金额: $ 225.13万
• 依托单位: RENEURON LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=103239
• 关键词: Cell2Sell; commercial; scale; next; generation

This project will develop a next generation industrialised cGMP platform for the production of ReNeuron's allogeneic stem cell products which target significant, growing areas of unmet clinical need. The recent Advanced Therapy Medicinal Products Taskforce of the Medicines Manufacturing Industrial Partnership has identified that the ATMP industry is at a critical stage with the focus now on manufacturing industrialisation in order to commercialise these therapies further strengthening the UKs position as a global hub for researching, developing, manufacturing and adopting regenerative medicine. Developing the UK as a major progressive global hub for the ATMP sector will leverage further investments. This project involves organisations in Great Britain and will result in an at scale, validatable, cGMP manufacturing process for clinical and commercial supply. It will create and secure jobs in the UK, accelerate the development of skills and capabilities for individuals and organisations. ReN's products are currently in clinical trials in Stroke, Critical Limb Ischemia and Retinitis Pigmentosa, and therefore have the potential to significantly improve quality of life for large numbers of patients in areas of unmet clinical need, reducing the costs of social care therefore saving money in the economy.

该项目将开发下一代工业化 cGMP 平台，用于生产 ReNeuron 的同种异体干细胞产品，这些产品针对未满足临床需求的重要且不断增长的领域。药品制造工业合作伙伴关系的先进治疗药物产品工作组最近发现，ATMP 行业正处于关键阶段，现在的重点是制造工业化，以便将这些疗法商业化，进一步加强英国作为研究、开发、制造和采用再生医学的全球中心的地位。将英国发展成为 ATMP 行业的主要进步全球中心将吸引更多投资。该项目涉及英国的组织，将为临床和商业供应提供大规模、可验证的 cGMP 制造工艺。它将在英国创造和保障就业机会，加速个人和组织技能和能力的发展。 ReN 的产品目前正在进行中风、严重肢体缺血和色素性视网膜炎的临床试验，因此有可能显着改善临床需求未满足领域的大量患者的生活质量，降低社会护理成本，从而节省经济资金。