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

该提案旨在提供资本资金，以提供设备和设施，改善英国干细胞银行提供的多能干细胞的库和表征，作为研究和临床应用的种子库。干细胞系作为研究和开发细胞疗法的起始材料，其建库、表征和质量控制的关键流程的自动化将显著提高细胞建库和检测的速度和质量。这些提高的效率将主要集中在工作人员的“接触时间”方面，其中一些银行功能的自动化以及QC和研究的样品制备时间的减少将释放大量的工作人员时间，以增强临床种子库的表征。这种简化将提高电池产品的质量和一致性：最大限度地减少工艺可变性，提高稳健性和可靠性。它还将提高世行在关键安全特性方面开展基础开发工作的能力，这些特性将确定用于治疗的细胞系的适用性，例如研究遗传稳定性以及在建库和扩大体外培养后表型和功能的维持。这些信息对于利用这些细胞进行基于细胞的药物至关重要。它还将使银行能够为临床和制造社区提供进一步的支持，以开发临床hESC和hiPSC系。该设备还将用于与学术，监管，中小企业和制药合作伙伴的众多当前和拟议合作中，其中UKSCB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.