NSPOMdb:非无菌产品中令人反感的微生物的精选数据集
Yanxiang Shen1,2, Minghui Song2, Yangtai Liu3
1State Key Laboratory of Microbial Metabolism, Joint International Laboratory on Metabolic & Developmental Sciences, School of Life Sciences & Biotechnology, Shanghai Jiao Tong University, Shanghai, 200240, China.
Scientific data
|December 2, 2025
概括
非无菌产品 (NSP) 中的微生物污染存在风险,但目前的指导方针有限. 一个新的数据集 (NSPOMdb) 确定了89种潜在的令人反感的微生物 (OMs),并提供了改善NSP风险评估的工具.
科学领域:
- 微生物学 微生物学
- 制药科学 制药科学
- 风险管理 风险管理
背景情况:
- 非无菌产品 (NSP) 中的微生物污染对患者安全和产品质量构成重大风险.
- 目前对令人反感的微生物 (OMs) 的监管标准和药典指南有限,未能解决所有已识别的污染物,导致产品召回.
- 对于NSP,现有的风险评估实践需要加强,以涵盖更广泛的潜在微生物污染物.
研究的目的:
- 开发一个全面的数据集 (NSPOMdb),整合历史召回数据,微生物特征和风险分析,用于识别和评估NSP中的潜在OM.
- 从1360个NSP的历史召回事件中策划89个潜在的OM的列表,为每一个提供详细的注释.
- 提供一个实用的框架和在线工具 (ARG-VFG-finder) 来改善NSP行业的微生物风险管理.
主要方法:
- 汇编和分析了1360个历史非无菌产品召回事件.
- 创建非无菌产品可反对微生物数据集 (NSPOMdb),为89个潜在的OMS提供全面的注释.
- 对39,626个OM序列的基因组分析,以确定抗微生物耐药性和病毒性基因.
- 开发ARG-VFG-finder在线工具,用于预测抗微生物耐药性和病毒性基因.
主要成果:
- NSPOMdb数据集包括89个潜在的OM,详细描述了形态,生理,生化,基因组和与风险相关的特征.
- 基因组分析显示,在NSP中发现的常见污染物中,存在广泛的抗微生物耐药性和毒性基因.
- 该ARG-VFG-finder工具可用于预测潜在的OMs中的抗菌素耐药性和毒性基因.
结论:
- 在NSPOMdb提供了一个有价值的资源,用于识别和评估在非无菌产品中令人反感的微生物.
- 基因组洞察力突出了常见NSP污染物的耐药性和毒性因素的普遍性,强调了需要加强风险评估的必要性.
- 开发的框架和工具有助于在非无菌产品行业中改进微生物风险管理策略.
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