Human mesenchymal stem/stromal cells (hMSCs) present a key therapeutic cellular intervention for use in cell and gene therapy (CGT) applications due to their immunomodulatory properties and multi-differentiation capability. Some of the indications where hMSCs have demonstrated pre-clinical or clinical efficacy to improve outcomes are cartilage repair, acute myocardial infarction, graft versus host disease, Crohn’s disease and arthritis. The current engineering challenge is to produce hMSCs at an affordable price and at a commercially-relevant scale whilst minimising process variability and manual, human operations. By employing bioreactors and microcarriers (due to the adherent nature of hMSCs), it is expected that production costs would decrease due to improved process monitoring and control leading to better consistency and process efficiency, and enabling economies of scale. This approach will result in off the shelf (allogeneic) hMSC-based products becoming more accessible and affordable. Importantly, cell quality, including potency, must be maintained during the bioreactor manufacturing process. This review aims to examine the various factors to be considered when developing a hMSC manufacturing process using microcarriers and bioreactors and their potential impact on the final product. As concluding remarks, gaps in the current literature and potential future areas of research are also discussed.

人间充质干/基质细胞（hMSCs）由于其免疫调节特性和多重分化能力，成为细胞和基因治疗（CGT）应用中的关键细胞治疗手段。hMSC已显示出临床前或临床上可改善疗效的适应症包括软骨修复，急性心肌梗塞，移植物抗宿主病，克罗恩病和关节炎。当前的工程挑战是要以可承受的价格和具有商业意义的规模生产hMSC，同时最大程度地减少过程可变性和人工操作。通过使用生物反应器和微载体（由于hMSC的粘附性），预计由于改进的过程监控和控制导致更好的一致性和过程效率，生产成本将降低。并实现规模经济。这种方法将导致现成的（同种异体的）基于hMSC的产品变得更加容易获得和负担得起。重要的是，在生物反应器制造过程中必须保持细胞质量，包括效能。这篇综述旨在研究在开发使用微载体和生物反应器的hMSC制造工艺时要考虑的各种因素，以及它们对最终产品的潜在影响。作为结束语，还讨论了当前文献中的空白和潜在的未来研究领域。这篇综述旨在研究在开发使用微载体和生物反应器的hMSC制造工艺时要考虑的各种因素，以及它们对最终产品的潜在影响。作为结束语，还讨论了当前文献和潜在的未来研究领域中的空白。这篇综述旨在研究在开发使用微载体和生物反应器的hMSC制造工艺时要考虑的各种因素，以及它们对最终产品的潜在影响。作为结束语，还讨论了当前文献中的空白和潜在的未来研究领域。