活体生物药：生物技术推动的创新药研发前沿

Live biotherapeutic products: the forefront of innovative drug development driven by biotechnology

摘要:

随着微生物组学研究的深入，越来越多的研究证据显示微生物与人体的健康密切相关。20世纪，人们发现了益生菌，并将其作为有健康功效的食品或膳食补充剂使用。21世纪以来，随着人体微生物组学、DNA合成与测序，以及基因编辑等技术的飞速发展，微生物在人体健康方面展示出更为广阔的应用前景。近年来，在新药研发上，提出了“下一代益生菌”的概念，将微生物作为“活体生物药(live biotherapeutic products, LBP)”进行研究和开发。简单地说，LBP是活菌药物，可以用于预防或治疗人类的某些疾病和适应症。LBP因其独特的优势，成为了新药研发领域的前沿方向，具有十分广阔的发展前景。本文着重从生物技术角度介绍LBP的类型和研究进展，并总结了LBP开发所面临的挑战以及对未来的展望，以期为LBP技术的发展与产品开发提供参考。

Abstract:

As human microbiome research advances, a large body of evidence shows that microorganisms are closely related to human health. Probiotics were discovered and used as foods or dietary supplements with health benefits in the last century. Microorganisms have shown broader application prospects in human health since the turn of the century, owing to the rapid development of technologies such as microbiome analysis, DNA synthesis and sequencing, and gene editing. In recent years, the concept of "next-generation probiotics" has been proposed as new drugs, and microorganisms are considered as "live biotherapeutic products (LBP)". In a nutshell, LBP is a living bacterial drug that can be used to prevent or treat certain human diseases and indications. Because of its distinct advantages, LBP has risen to the forefront of drug development research and has very broad development prospects. This review introduces the varieties and research advances on LBP from a biotechnology standpoint, followed by summarizing the challenges and opportunities for LBP clinical implementations, with the aim to facilitate LBP development.