Centre for Biological Engineering, Loughborough University, Leicestershire, UK; Wolfson Centre for Stem Cells, Tissue Engineering and Modelling (STEM), School of Medicine, Nottingham, UK.
Akron Biotechnology, Boca Raton, Florida, USA; MIT Industrial Performance Center, Cambridge, Massachusetts, USA.
Cytotherapy. 2019 Feb;21(2):224-233. doi: 10.1016/j.jcyt.2019.01.003. Epub 2019 Feb 13.
Cell and gene therapies have demonstrated excellent clinical results across a range of indications with chimeric antigen receptor (CAR)-T cell therapies among the first to reach market. Although these therapies are currently manufactured using patient-derived cells, therapies using healthy donor cells are in development, potentially offering avenues toward process improvement and patient access. An allogeneic model could significantly reduce aggregate cost of goods (COGs), potentially improving market penetration of these life-saving treatments. Furthermore, the shift toward offshore production may help reduce manufacturing costs. In this article, we examine production costs of an allogeneic CAR-T cell process and the potential differential manufacturing costs between regions. Two offshore locations are compared with regions within the United States. The critical findings of this article identify the COGs challenges facing manufacturing of allogeneic CAR-T immunotherapies, how these may evolve as production is sent offshore and the wider implication this trend could have.
细胞和基因疗法在多种适应症中显示出了优异的临床效果，嵌合抗原受体 (CAR)-T 细胞疗法是首批上市的疗法之一。尽管这些疗法目前是使用患者来源的细胞制造的，但使用健康供体细胞的疗法正在开发中，这可能为工艺改进和患者获得提供了途径。同种异体模型可以显著降低总制造成本 (COG)，有可能提高这些救命疗法的市场渗透率。此外，向海外生产转移可能有助于降低制造成本。在本文中，我们研究了同种异体 CAR-T 细胞工艺的生产成本，以及不同地区之间的潜在差异制造成本。将两个海外地点与美国的地区进行了比较。本文的关键发现确定了同种异体 CAR-T 免疫疗法制造面临的 COG 挑战，随着生产转移到海外，这些挑战可能会如何演变，以及这种趋势可能产生的更广泛影响。
