Automation of Cell Banking & Characterisation Pathways at the UKSCB: Underpinning Delivery of a Core Component of the UK Infrastructure for Regen Med

该提案是为了提供资本资金，以提供设备和设施，以改善英国干细胞库提供的多潜能干细胞的银行和特性，作为研究和临床应用的种子储备。干细胞系作为研究和开发细胞疗法的起始材料，其库、特征和质量控制中的关键过程的自动化将大大提高细胞库和测试的速度和质量。这些提高的效率将主要集中在员工“联系时间”方面，一些银行职能的自动化以及QC和研究样本准备时间的减少将使员工腾出大量时间来增强临床种子库的特征。这种简化将提高电池产品的质量和一致性：将工艺变异性降至最低，并增强稳健性和可靠性。它还将加强世行在关键安全特性方面开展基础开发工作的能力，这些工作将确定用于治疗的细胞系的适宜性，例如研究遗传稳定性以及在银行和扩大体外培养后的表型和功能的维持。这些信息对于这些细胞用于基于细胞的药物是至关重要的。它还将使世行能够在临床hESC和hiPSC系列的开发方面为临床和制造业提供进一步的支持。该设备还将用于目前和拟议中的许多与学术、监管、中小企业和制药合作伙伴的合作中，其中英国商会正在提供支持，以促进商业产品的监管批准。

The proposal is for capital funding to provide equipment and facilities for improving the banking and characterisation of pluripotent stem cells provided by the UK Stem Cell Bank as seed stocks for research and clinical applications. The automation of key processes in the banking, characterisation and quality control of stem cell lines, intended as starting materials for research and development of cellular therapies, will generate significant improvements in the speed and quality of cell banking and testing. These increased efficiencies will be focused mainly in the area of staff "contact time" where automation of some banking functions and reduction in sample preparation time for QC and research will free up significant staff time for enhanced characterisation of clinical seed stocks. This streamlining will result in improved quality and consistency of cell products: minimising process variability and enhancing robustness and reliability. It will also enhance the Bank's ability to conduct underpinning development work on key safety characteristics which will define the suitability of cell lines used for therapy, such as studies of genetic stability and maintenance of phenotype and function after banking and extended in vitro culture. This information will be essential for the utility of these cells for cell-based medicines. It will also enable the Bank to provide further support to the clinical and manufacturing communities in the development of both clinical hESC and hiPSC lines. The equipment will also be used in the numerous current and proposed collaborations with academic, regulatory, SME and pharmaceutical partners, in which the UKSCB is providing support to facilitate regulatory approval of commercial products.