Development of synthetic biotics as treatment for human diseases.

Development of synthetic biotics as treatment for human diseases.
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DOI:
10.1093/synbio/ysac001
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发表时间:
2021
期刊:
Synthetic biology (Oxford, England)
影响因子:
--
通讯作者:
Brennan AM
Brennan AM
中科院分区:
其他
文献类型:
--
作者:
Brennan AM

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合成生物学的进步使得能够产生经过基因改造具有特定治疗效果的细菌菌株。这些合成生物制剂也被广泛称为工程活性疗法,作为一种新的治疗方式具有巨大的潜力,其中一些已进入临床和人体测试。这篇综述概述了合成生物素的一些独特属性以及其作为处方产品开发过程中面临的一些挑战。讨论了监管考虑因素,并提供了已进入 2 期测试的项目的案例研究:用于治疗 PKU 的 SYNB1618。
Advances in synthetic biology have allowed the generation of strains of bacteria that are genetically altered to have specific therapeutic benefits. These synthetic biotics, also widely referred to as engineered living therapeutics, have tremendous potential as a new therapeutic modality, and several have advanced into the clinic and human testing. This review outlines some of the unique attributes of synthetic biotics as well as some of the challenges in their development as prescription products. Regulatory considerations are discussed, and a case study of a program that has advanced into Phase 2 testing is provided: SYNB1618 for the treatment of PKU.
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