合成生物制剂治疗人类疾病的发展

IF 3.2 4区生物学 Q1 Agricultural and Biological Sciences

Synthetic Biology Pub Date : 2022-01-31 DOI:10.1093/synbio/ysac001

A. Brennan

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引用次数: 9

摘要

合成生物学的进步已经允许产生基因改变的细菌菌株，具有特定的治疗益处。这些合成生物制剂，也被广泛地称为工程生物治疗剂，作为一种新的治疗方式具有巨大的潜力，其中一些已经进入临床和人体试验。本文概述了合成生物制剂的一些独特属性，以及它们作为处方产品发展中的一些挑战。讨论了监管方面的考虑，并提供了一个已进入二期试验的项目的案例研究:用于治疗PKU的SYNB1618。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Development of synthetic biotics as treatment for human diseases

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.

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来源期刊

Synthetic Biology Agricultural and Biological Sciences-Agricultural and Biological Sciences (miscellaneous)

CiteScore

4.50

自引率

3.10%

发文量

审稿时长

25 weeks