Sterility Testing for Hematopoietic Stem Cells.
Sterility Testing for Hematopoietic Stem Cells.
复制标题
造血干细胞的无菌测试。
DOI：
10.1128/jcm.01654-22
复制
发表时间：
2023
影响因子：
9.4
通讯作者：
Lau,AnnaF
中科院分区：
文献类型：
--
作者：
Cundell,Tony;Atkins,JWade;Lau,AnnaF
在过去的二十年里，快速的技术进步导致了细胞和基因治疗产品的广泛采用，用于治疗各种疾病状态。在这项研究中，我们回顾了2003年至2021年间的文献，以提供与来自外周血、骨髓和脐带血的造血干细胞(HSCs)微生物污染相关的总体趋势的总结。我们简要介绍了美国食品和药物管理局(FDA)对人体细胞、组织以及细胞和组织基产品(HCT/Ps)的监管背景，自体(第361节)和异体(351节)HSC产品的无菌测试期望，并讨论了与注入受污染的HSC产品相关的临床风险。最后，我们讨论了当前良好的组织规范(CGTP)和当前的良好制造规范(CGMP)分别基于361节和351节的分类对HSC的制造和测试的期望。我们提供现场实践的评论，并讨论与先进技术保持同步的专业标准更新的迫切需要，目的是澄清对制造和测试设施的期望，以提高机构的标准化。
Over the last two decades, rapid technological advances have led to the wide adoption of cell and gene therapy products for the treatment of a variety of disease states. In this study, we reviewed the literature between 2003 and 2021 to provide a summary of overarching trends associated with microbial contamination in hematopoietic stem cells (HSCs) derived from peripheral blood, bone marrow, and cord blood. We provide a brief background on the regulatory context for human cells, tissues, and cellular and tissue-based products (HCT/Ps) as regulated by the US Food and Drug Administration (FDA), sterility testing expectations for autologous (Section 361) and allogeneic (Section 351) HSC products, and discuss clinical risks associated with the infusion of a contaminated HSC product. Finally, we discuss the expectations for current good tissue practices (cGTP) and current good manufacturing practices (cGMP) for the manufacturing and testing of HSC based on Section 361 and Section 351 categorization, respectively. We provide commentary on what is practiced in the field and discuss the critical need for updates to professional standards that keep pace with advancing technologies with an aim to clarify expectations for manufacturing and testing facilities to improve standardization across institutions.