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Scale up of optical fractionation for bio-processing

生物加工光学分级的放大

基本信息

批准号：
EP/L022370/1
负责人：
Michael MacDonald
金额：
$ 21.15万
依托单位：
University of Dundee
依托单位国家：
英国
项目类别：
Research Grant
财政年份：
2014
资助国家：
英国
起止时间：
2014 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=EP%2FL022370%2F1
关键词：
Scale up optical fractionation bio

项目摘要

Human pluripotent stem cells are the primary template cells for nearly all the cell types within the body. The exclusivity of these cells arises from their unmatched capability to remain in an unspecialised state until they are induced to differentiate (change from being a stem cell to a cell that has a specific function in the organism). A major challenge of regenerative medicine is to exploit these twin properties to provide wide-ranging novel therapies through the manufacture of beneficial cell types at scale. To date, one of the principal bottlenecks in the development of large scale cell therapies has been the lack of manufacturing-suitable cell separation and purification technologies, effectively limiting the production of products pure enough for wide scale human trials.This bottleneck is caused by the need for safety and efficacy in sorting cells to high purity without adding antibodies or other modifying agents, in order to remove residual pluripotent cells and also for the identification and definition of the cells in the final product. Hence what regenerative medicine needs in order to be translated into a manufacturing process is a scalable label-free sorting technology. This implies passive sorting which can both be done without labelling and in a highly parallelised manner. However, passive cell sorting technologies require a pathfinder application to fully demonstrate its critical importance to the progression of cell therapy commercialisation. We intend to fulfil this key step by developing scalable passive optical sorting technologies for large scale red blood cell (RBC) manufacture.The UK has a particularly strong research base in regenerative medicine, yet the opportunities for protecting IP in the development of due to an EU Court of Justice ruling which means that cells derived from human embryonic stem cells (hESCs) cannot be patented. This means that the IP supporting any translation of regenerative medicine involving hESCs will come from the process by which cells are derived (which is still open to patenting). As a result the value of the process is increased, including IP based on manufacturing. Hence, cell sorting techniques developed for regenerative medicine will form the backbone of value creation in hESC derived cell therapies and will be an important mechanism for keeping UK (and European) research competitive with US and Asian competitors.

人类多能干细胞是体内几乎所有细胞类型的主要模板细胞。这些细胞的排他性源于它们无与伦比的能力，能够保持非特化状态，直到它们被诱导分化（从干细胞转变为在生物体中具有特定功能的细胞）。再生医学的一个主要挑战是利用这些孪生特性，通过大规模生产有益细胞类型来提供广泛的新疗法。迄今为止，大规模细胞疗法开发的主要瓶颈之一是缺乏适合生产的细胞分离和纯化技术，有效地限制了足够纯度以进行大规模人体试验的产品的生产。这一瓶颈是由于需要在不添加抗体或其他修饰剂的情况下将细胞分选到高纯度，以去除残留的多能细胞，并进行鉴定和鉴定，从而实现安全性和有效性，从而造成这一瓶颈。最终产品中细胞的定义。因此，为了将再生医学转化为制造过程，需要一种可扩展的无标签分选技术。这意味着被动排序可以在没有标签的情况下以高度并行的方式完成。然而，被动细胞分选技术需要探路者应用程序来充分证明其对细胞治疗商业化进程的至关重要性。我们打算通过开发用于大规模红细胞 (RBC) 生产的可扩展被动光学分选技术来完成这一关键步骤。英国在再生医学方面拥有特别强大的研究基础，但由于欧盟法院的一项裁决，在开发过程中保护知识产权的机会，这意味着源自人类胚胎干细胞 (hESC) 的细胞不能获得专利。这意味着支持任何涉及 hESC 的再生医学转化的知识产权将来自细胞衍生的过程（该过程仍然开放申请专利）。结果，工艺的价值增加了，包括基于制造的知识产权。因此，为再生医学开发的细胞分选技术将构成 hESC 衍生细胞疗法价值创造的支柱，并将成为保持英国（和欧洲）研究与美国和亚洲竞争对手竞争的重要机制。