Developing the Nanokick Bioreactor for Commercialisation and Cell Therapy

工程化骨移植正在形成一个新的市场，包括含有间充质干细胞(MSCs)的产品。然而，骨髓间充质干细胞不产生骨，成骨细胞产生骨。BBSRC之前的资金帮助我们开发了Nanokick生物反应器，用于无化学物质供应成骨、骨形成和细胞。在这里，我们将解决技术、监管和商业目标，以制造用于骨移植的真正可扩展的同种异体细胞疗法。我们已经为2021年的第一次人类研究获得了资金。然而，该项目将解决为大型试验提供临床级细胞并最终作为市场治疗产品所面临的监管和工艺特定的技术挑战。可规模化制造的同样挑战已经减缓或停止了许多细胞疗法的进展，因此，这里正在开发的工艺预计将在细胞疗法领域产生更广泛的影响。

There is a >£1B market emerging for engineered bone graft, including products containing mesenchymal stem cells (MSCs). However, MSCs don't produce bone, osteoblasts do. Previous BBSRC funding has helped develop our Nanokick bioreactor for chemical-free supply of osteogenic, bone forming, cells. Here, we will address technical, regulatory and commercial objectives towards manufacture of a genuinely scalable allogeneic cell therapy for bone grafting. We have already secured funding for a first-in-man study in 2021. However, this project will address the regulatory and process specific technological challenges to supplying clinical grade cells for large trials and, ultimately, as a marketed therapeutic product. This same challenge of scalable manufacture has slowed or ceased progress of many cellular therapies, therefore the processes being developed here are expected to have wider impact in the cell therapy sector.