Microbial Contamination Control and Related Standards for Human Stem Cell Preparations

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.