经纯化的微生物组治疗制品的制造工艺降低了供体粪便中潜在细菌病原体传播的风险。
Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool.
机构信息
Seres Therapeutics, Cambridge, Massachusetts, USA.
Mayo Clinic, Rochester, Minnesota, USA.
出版信息
J Infect Dis. 2023 Nov 11;228(10):1452-1455. doi: 10.1093/infdis/jiad298.
BACKGROUND
Although fecal microbiota transplant has been used to prevent recurrent Clostridioides difficile infection (rCDI), documented pathogen transmissions highlight inherent safety risks of minimally processed stool. We describe manufacturing processes for fecal microbiota spores, live (VOWST; VOS, formerly SER-109), a microbiota-based oral therapeutic of Firmicutes spores.
METHODS
Bacterial inactivation kill curves were obtained after ethanol exposure for 4 model organisms spiked into process intermediates.
RESULTS
Bacterial log reduction factors ranged from 6.5 log10 to 7.4 log10 and lysis of spiked organisms occurred rapidly within 30 seconds.
CONCLUSIONS
These experiments demonstrate substantial and rapid inactivation of representative organisms, supporting the potential benefit of VOS manufacturing processes to mitigate risk.
背景
虽然粪便微生物群移植已被用于预防复发性艰难梭菌感染（rCDI），但已记录的病原体传播凸显了未经充分处理的粪便所固有的安全风险。我们描述了 Firmicutes 孢子的粪便微生物群孢子、活菌（VOWST；VOS，前身为 SER-109）的制造工艺，VOWST 是一种基于微生物群的口服治疗药物。
方法
将 4 种模式生物的混合物加入到中间产物中，然后进行乙醇暴露，获得细菌失活动力学杀灭曲线。
结果
细菌对数减少因子范围为 6.5 log10 至 7.4 log10，且混合物中的目标生物在 30 秒内迅速溶解。
结论
这些实验表明代表生物的大量且快速失活，支持 VOS 制造工艺降低风险的潜在益处。
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