Cell2Sell: commercial scale next generation platform for allogeneic stem cell production
Cell2Sell: commercial scale next generation platform for allogeneic stem cell production
批准号:
103239
负责人:
金额:
$225.13万
依托单位:
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
项目状态:
已结题
起止时间:
2017 至 --
中文摘要
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增长领域。最近,药品制造工业伙伴关系的高级治疗药品工作组已经确定,ATMP行业正处于关键阶段,现在的重点是制造工业化,以使这些疗法商业化,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进一步利用投资。该项目涉及英国的组织,将产生用于临床和商业供应的大规模、可验证的cGMP生产工艺。它将在英国创造和确保就业机会,加速个人和组织的技能和能力的发展。ReN的产品目前正在进行中风、严重肢体缺血和视网膜色素变性的临床试验,因此有可能显著改善大量未满足临床需求的患者的生活质量,降低社会护理成本,从而节省经济资金。
英文摘要
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.
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国内基金
海外基金
低辐射空间环境下商用多核处理器层次化软件容错技术研究
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批准号:90818016
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项目类别:重大研究计划
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资助金额:50.0万元
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批准年份:2008
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负责人:傅忠传
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依托单位: