Stem Cell Transplantation and Cellular Therapies, Memorial Sloan Kettering (MSK) Kids, MSK Cancer Center, New York, NY, USA.
Br J Haematol. 2021 Jul;194(1):14-27. doi: 10.1111/bjh.17297. Epub 2021 Feb 2.
Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, 'off-the shelf' treatments. Such strategies will allow broader patient access and wide product utilisation.
无关脐带血(CB)单位已经制造、全面检测和储存,是造血干细胞移植和细胞疗法的高质量产品,也是细胞扩增、细胞工程或细胞重编程技术的最佳起始材料。CB 库在细胞治疗产品的现行良好生产规范的开发和实施方面一直处于领先地位。分享他们的技术和监管经验将有助于推进所有的细胞疗法,无论是源自 CB 还是其他来源,特别是当它们从自体、个体化制造的产品过渡到储存的、现成的治疗方法时。这些策略将允许更广泛的患者获得和广泛的产品利用。