Andrea R Watson, Wei-An Chen, Willem van Schaik, Jason M Norman
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Abstract
In 2016, the US Food and Drug Administration published guidance for the early development of live biotherapeutic products (LBPs). Of particular importance is the characterization of LBP strains and the potential transfer of antimicrobial resistance (AMR) genes to relevant microbial organisms in the recipients microbiota. Van der Lelie et al, make unsupported claims that the LBP strain VE202-06 encodes a transferable vancomycin resistance element. Here we provide our analysis of the potential transfer of AMR by strain VE202-06. These data indicate that strain VE202-06 has no risk of transferring AMR to relevant microbial organisms.
2016 年，美国食品和药物管理局发布了活生物治疗产品（LBPs）早期开发指南。其中尤为重要的是枸杞多糖菌株的特性以及抗菌药耐药性（AMR）基因向受体微生物群中相关微生物的潜在转移。Van der Lelie 等人声称枸杞多糖菌株 VE202-06 编码可转移的万古霉素抗性元件，但这一说法没有得到证实。在此，我们对 VE202-06 菌株可能转移 AMR 的情况进行了分析。这些数据表明，菌株 VE202-06 没有向相关微生物转移 AMR 的风险。
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