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合成生物制剂作为人类疾病治疗手段的研发。

Development of synthetic biotics as treatment for human diseases.

作者信息

Brennan Aoife M

机构信息

Synlogic Operating Company, Cambridge, MA, USA.

出版信息

Synth Biol (Oxf). 2022 Jan 31;7(1):ysac001. doi: 10.1093/synbio/ysac001. eCollection 2021.

DOI:10.1093/synbio/ysac001
PMID:35350191
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8944296/
Abstract

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.

摘要

合成生物学的进展使得能够产生经过基因改造以具有特定治疗益处的细菌菌株。这些合成生物制剂，也被广泛称为工程化活体疗法，作为一种新的治疗方式具有巨大潜力，并且有几种已进入临床和人体试验阶段。本综述概述了合成生物制剂的一些独特特性以及它们作为处方药开发过程中的一些挑战。讨论了监管方面的考虑因素，并提供了一个已进入2期试验的项目的案例研究：用于治疗苯丙酮尿症的SYNB1618。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b870/8944296/147a06cb2330/ysac001f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b870/8944296/b5540aac7b4d/ysac001f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b870/8944296/147a06cb2330/ysac001f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b870/8944296/b5540aac7b4d/ysac001f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b870/8944296/147a06cb2330/ysac001f2.jpg

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