人源干细胞制剂微生物污染控制及相关规范

Microbial Contamination Control and Management of Human-derived Stem Cell Preparations and Related Regulations

  • 摘要: 人源干细胞制剂及相关产品在国内外已广泛用于难治性疾病的临床试验及治疗,由于干细胞制剂制备过程复杂,目前微生物检测法难以满足干细胞制剂安全性检验相关需求,特别是医疗机构内的放行检验,因此研发新的替代方法使干细胞制剂能够安全及时用于临床迫在眉睫。本文从干细胞制剂原材料选择、制备过程、放行检验、治疗过程以及留样检验过程阐述干细胞制剂涉及到的微生物检测环节及相关制度规范,以期为干细胞制剂临床应用中的微生物质量控制提供依据。

     

    Abstract: Stem cell preparations and associated products have been widely used in clinical trials and treatment of refractory diseases at home and abroad. Due to the complex preparation process of stem cell preparations, the current microbial examination methods are difficult to meet the relevant needs of safety testing of stem cell preparations, especially the release examination in medical institutions. It is urgent to develop new methods to make stem cell preparations safe and timely for clinical use. This article elaborates on the control process and standards for microbial contaminating in human stem cell preparations, covering raw material selection, preparation processes, release testing, clinical application and sample retention. The aim is to provide a basis for microbial quality control in the clinical application of stem cell preparations.

     

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