Harrison Richard P, Medcalf Nicholas, Rafiq Qasim A
Centre for Biological Engineering, Holywell Park, Loughborough University, Loughborough, LE11 3TU, UK.
Wolfson Centre for Stem cells, Tissue Engineering & Modelling (STEM), The University of Nottingham, Centre for Biomolecular Sciences, University Park, Nottingham, NG7 2RD, UK.
Regen Med. 2018 Mar;13(2):159-173. doi: 10.2217/rme-2017-0103. Epub 2018 Mar 6.
Manufacturing methods for cell-based therapies differ markedly from those established for noncellular pharmaceuticals and biologics. Attempts to 'shoehorn' these into existing frameworks have yielded poor outcomes. Some excellent clinical results have been realized, yet emergence of a 'blockbuster' cell-based therapy has so far proved elusive.
MATERIALS & METHODS: The pressure to provide these innovative therapies, even at a smaller scale, remains. In this process, economics research paper, we utilize cell expansion research data combined with operational cost modeling in a case study to demonstrate the alternative ways in which a novel mesenchymal stem cell-based therapy could be provided at small scale.
RESULTS & CONCLUSIONS: This research outlines the feasibility of cell microfactories but highlighted that there is a strong pressure to automate processes and split the quality control cost-burden over larger production batches. The study explores one potential paradigm of cell-based therapy provisioning as a potential exemplar on which to base manufacturing strategy.
基于细胞的疗法的制造方法与针对非细胞药物和生物制品所确立的方法显著不同。试图将这些方法“硬塞进”现有框架已产生了不佳的结果。虽然已经取得了一些出色的临床成果，但迄今为止，一种“重磅炸弹”式的基于细胞的疗法仍难以出现。
即便规模较小，提供这些创新疗法的压力依然存在。在此过程中，在一篇经济学研究论文里，我们利用细胞扩增研究数据并结合运营成本建模，通过一个案例研究来展示以小规模提供一种新型间充质干细胞疗法的替代方式。
本研究概述了细胞微型工厂的可行性，但强调了在自动化流程以及将质量控制成本负担分摊到更大生产批次方面存在强大压力。该研究探索了一种基于细胞的疗法供应的潜在模式，作为制定制造策略的一个潜在范例。
