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 prepa-ration 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.

Adeno-associated virus (AAV)-based gene therapies hold broad application prospects in the treatment of rare and genetic diseases. However, emerging safety concerns such as dose-dependent immune responses, target organ toxicity, and genomic integration have increasingly become apparent, significantly limiting their clinical translation. This article begins by examining the major manifestations of AAV vector toxicity, delvesinto the mechanisms by which factors such as capsid structure, genome design, and expression regulation contribute to toxic responses, and provides a systematic review of the advances in current mainstream detection technologies—including droplet digital PCR, single-cell RNA sequencing, bioluminescence imaging, and liquid biopsy—for toxicity identification and monitoring. Furthermore, it explores mitigation strategies such as capsid engineering, route of administration optimization, immune modulation, and personalized interventions. The paper proposes a conceptual "design-monitor-intervene" closed-loop control framework, aiming to offer valuable insights for safety evaluation, clinical application optimization, and regulatory strategy development of AAV-based gene therapeutics.

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.

Objective:To evaluate and study the current status of safety and quality control of moxifloxacin hydro-chloride and sodium chloride injection.Methods:Fifteen production enterprises nationwide producing moxifloxacin hydrochloride and sodium chloride injection were sampled and tested according to each manufacturer's respective quality standards.Additionally,the safety-related items of"bacterial endotoxins"and"abnormal toxicity"were further studied and expanded upon.The rationality of the existing standards was analyzed.Results:According to the standard test,the qualification rate of 187 batches of moxifloxacin hydrochloride was 100％.However,compa-ring the quality standards used by various enterprises,it was found that there are significant differences in their re-quirements for bacterial endotoxin projects and abnormal toxicity projects.After using a unified and stricter standard for expansion testing,all 187 batches of samples still passed.Conclusion:The overall quality of moxifloxacin hydrochloride and sodium chloride injection in China is satisfactory in terms of safety control.It is recommended to unify the safety standards according to the draft quality standard for"moxifloxacin hydrochloride and sodium chlo-ride injection"issued by the National Pharmacopoeia Commission.