Scale up of optical fractionation for bio-processing

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，即保持在非专门状态，直到它们被诱导分化（从干细胞变成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双重特性，通过大规模生产有益的细胞类型来提供广泛的新疗法。迄今为止，大规模细胞疗法发展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以用于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的安全性和有效性，以便除去残留的多能细胞，并且还用于最终产品中细胞的鉴定和定义。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记的情况下以高度并行的方式进行。然而，被动细胞分选技术需要一个探路者应用程序，以充分证明其对细胞治疗商业化进展的至关重要性。英国在再生医学方面拥有特别强大的研究基础，但由于欧盟法院的裁决，从人类胚胎干细胞（hESC）衍生的细胞不能获得专利，因此在开发过程中保护知识产权的机会非常有限。这意味着支持任何涉及hESCs的再生医学转化的知识产权将来自细胞衍生过程（该过程仍可申请专利）。因此，该过程的价值增加，包括基于制造的IP。因此，为再生医学开发的细胞分选技术将成为hESC衍生细胞疗法创造价值的支柱，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。

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.