Microbial Contamination Control and Related Standards for Human Stem Cell Preparations

Cuizhu CHEN; Changfa HUANG; Qian LI; Ze WU; Chunran CAO; Zhihong WU

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Microbial Contamination Control and Related Standards for Human Stem Cell Preparations

VernacularTitle:人源干细胞制剂微生物污染控制及相关规范
Author: Cuizhu CHEN ¹ ; Changfa HUANG ² ; Qian LI ³ ; Ze WU ¹ ; Chunran CAO ³ ; Zhihong WU ¹
Author Information

1. Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;National Infrastructures for Translational Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;
2. Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;National Infrastructures for Translational Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;Department of Orthopaedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;Graduate School, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;
3. Beijing Institute for Drug Control, Key Laboratory for Safety Research and Evaluation of Innovative Drugs, State Drug Administration, Beijing 102206, China;
Publication Type:Journal Article
Keywords: stem cells; clinical therapy; microbe; quality control
From: Medical Journal of Peking Union Medical College Hospital 2024;16(6):1429-1436
CountryChina
Language:Chinese
Abstract:
Human stem cell preparations and related products have been widely utilized in clinical trials and treatments for refractory diseases both domestically and internationally. Due to the complexity of the preparation process for stem cell preparations, current microbial detection methods struggle to meet the safety testing requirements, particularly for release testing within medical institutions. Therefore, it is imperative to develop novel alternative methods to ensure the safe and timely clinical application of stem cell preparations. This article elaborates on the microbial testing procedures and relevant regulatory standards involved in stem cell preparations, covering aspects such as raw material selection, preparation processes, release testing, therapeutic application, and sample retention testing. The aim is to provide a foundation for microbial quality control in the clinical use of stem cell preparations.