Immuno-Gene Therapy Committee, International Society for Cell and Gene Therapy, Vancouver, BC, Canada; Department of Laboratory Medicine, Yale School of Medicine, Yale University, New Haven, CT.
Immuno-Gene Therapy Committee, International Society for Cell and Gene Therapy, Vancouver, BC, Canada; Department of Laboratory Medicine and Pathology, Mayo Clinic in Arizona, Phoenix, AZ.
Cytotherapy. 2022 Jan;24(1):27-31. doi: 10.1016/j.jcyt.2021.09.009. Epub 2021 Nov 19.
There is considerable interest in the next generation of personalized medicine, especially cell and gene therapy products such as chimeric antigen receptor T cells (CAR-Ts). Unlike other small molecules or pharmacologic drugs, most existing cell or cell-based gene therapy products (CGTs) require apheresis collection of the patient or donor, subsequent manufacture of the product, and final shipment of the product to the clinical site for infusion. Whereas traditional pharmaceutical drugs have involved the drug sponsor and the clinical site and clinical pharmacy, this new manufacturing paradigm has evolved, in many cases, to include an apheresis center, a cell processing lab, the sponsor's manufacturing facility, and a clinical site with or without a pharmacy. Here we report the results of a survey of current practices handling investigational CGTs conducted by the Immuno-Gene Therapy committee of the International Society of Cell and Gene Therapy.
人们对下一代个性化药物，特别是嵌合抗原受体 T 细胞（CAR-T）等细胞和基因治疗产品非常感兴趣。与其他小分子或药物不同，大多数现有的细胞或基于细胞的基因治疗产品（CGTs）需要采集患者或供体的血液，随后进行产品的制造，最后将产品运送到临床地点进行输注。传统的药物涉及药物赞助商和临床地点以及临床药剂师，而这种新的制造模式已经发展，在许多情况下，包括一个单采中心，一个细胞处理实验室，赞助商的制造设施，以及一个有或没有药房的临床地点。在这里，我们报告了国际细胞和基因治疗学会免疫基因治疗委员会对当前处理研究性 CGT 的实践调查结果。
