Applications of synthetic biology in medical diagnosis and treatment： technological breakthroughs and ethical issues

YANG Shuai; XU Yundong; JIN Fan

doi:10.12211/2096-8280.2025-033

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Applications of synthetic biology in medical diagnosis and treatment： technological breakthroughs and ethical issues

Invited Review | 更新时间：2026-03-07

- Applications of synthetic biology in medical diagnosis and treatment： technological breakthroughs and ethical issues
- Synthetic Biology Journal Vol. 7, Issue 1, Pages: 246-264(2026)
- 作者机构：
  
  1.中国科学院成都文献情报中心，四川成都 610299
  2.中国科学院大学经济与管理学院信息资源管理系，北京 100049
  3.中国科学院深圳先进技术研究院，合成生物学研究所，广东深圳 518055
- 作者简介：
- 基金信息：
- DOI：10.12211/2096-8280.2025-033
  CLC： Q81;B82
- Received：08 April 2025，
  
  Revised：2025-07-30，
  
  Published：28 February 2026
- 稿件说明：
移动端阅览
杨帅，徐韵东，金帆. 合成生物学在医学诊疗中的应用与伦理治理：技术突破与价值边界［J］. 合成生物学， 2026， 7（1）： 246-264

YANG Shuai， XU Yundong， JIN Fan. Applications of synthetic biology in medical diagnosis and treatment： technological breakthroughs and ethical issues［J］. Synthetic Biology Journal， 2026， 7（1）： 246-264
杨帅，徐韵东，金帆. 合成生物学在医学诊疗中的应用与伦理治理：技术突破与价值边界［J］. 合成生物学， 2026， 7（1）： 246-264 DOI： 10.12211/2096-8280.2025-033.

YANG Shuai， XU Yundong， JIN Fan. Applications of synthetic biology in medical diagnosis and treatment： technological breakthroughs and ethical issues［J］. Synthetic Biology Journal， 2026， 7（1）： 246-264 DOI： 10.12211/2096-8280.2025-033.

摘要

本文系统性地探讨了在医学诊疗中使用合成生物学的技术突破与价值边界。随着基因编辑、DNA合成与拼接、调控元件设计等使能技术的快速进步，合成生物学已从实验室走向临床应用，为多种疾病提供了突破传统治疗路径的干预策略。然而，这些技术创新也带来了复杂的伦理难题。本文从实用性、社会政治性和范畴性三个维度，分析了诊疗用合成生物学，尤其是基因编辑技术所面临的生物安全风险、双重用途困境、全球健康公平以及基因组完整性与人类尊严等多层次伦理议题，并提出了以人本原则、风险最小化和可持续发展为核心的伦理治理框架，同时分析了合成生物学跨文化治理经验对比与中国伦理治理模式的创新。通过技术与伦理的整合性思考，本文为合成生物学在医学诊疗领域的负责任创新提供了系统性参考，促进技术进步与伦理守护的和谐统一。

Abstract

This paper systematically investigates the technological breakthroughs and ethical issues of synthetic biology in the context of medical diagnosis and treatment. With the rapid evolution of enabling technologies such as gene editing

DNA synthesis and assembly

regulatory element design

and metabolic engineering

synthetic biology has been transformed from theoretical frameworks to practical clinical applications. These advances have unlocked new possibilities for precision therapy

particularly in treating genetic and complex diseases. However

these innovations also introduce profound ethical dilemmas that necessitate policy-making and practice as well. The study conceptualizes the ethical challenges of therapeutic synthetic biology from three dimensions: practical

sociopolitical

and categoriality. In the practical dimension

the primary concerns involve biosafety

off-target effect and clinical risk. The sociopolitical dimension explores biosecurity

demographics of biotechnologies

and global health equity

emphasizing the structural inequalities in access to advanced therapies. The categorical dimension raises fundamental concerns about genomic integrity

intergenerational ethics

and human dignity—issues that underscore the moral limits of applying biotechnology to human life. To address these complex issues

the paper proposes an ethical governance framework grounded in human-centered principles

risk minimization

sustainable development and systematic govermance model. It highlights the importance of systematized risk management

participatory governance. Furthermore

it examines comparative international governance models from Europe

the United States

and China

reflecting how differing political and cultural contexts shape regulatory responses to synthetic biology. Ultimately

the paper argues that responsible innovation in medical synthetic biology must balance technological progress with ethical stewardship

emphasize the continuous improvement of ethical supervision

and ensure that the direction of technological development is consistent with the common values of humanity through multi-disciplinary collaboration and public involvement. This integrated approach ensures that synthetic biology not only advances the frontiers of medicine

but also aligns with shared human values

social justice

and ecological safety. By doing so

it contributes to the sustainable and equitable application of biotechnology in enhancing human health.

关键词

Keywords

references

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