Applications and Ethical Governance of Synthetic Biology in Medical Diagnosis and Treatment： Technological Breakthroughs and Value Boundaries

doi:10.12211/2096-8280.2025-033

Abstract

Abstract:

This paper systematically investigates the technological breakthroughs and ethical boundaries 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 transitioned from theoretical frameworks to practical clinical applications. These advances have unlocked new possibilities for precision therapy, particularly in treating genetic and complex diseases, while also enhancing cell-based immunotherapies and biosensing diagnostics. However, these innovations introduce profound ethical dilemmas that necessitate comprehensive governance. The study conceptualizes the ethical challenges of therapeutic synthetic biology along three analytical 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, democratization 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 participation. 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.

Key words: Synthetic Biology, Gene Editing, Medical Diagnosis and Treatment, Ethical Governance, Biosafety

关键词: 合成生物学, 基因编辑, 医学诊疗, 伦理治理, 生物安全

CLC Number:

YANG Shuai, XU YunDong, JIN Fan. Applications and Ethical Governance of Synthetic Biology in Medical Diagnosis and Treatment： Technological Breakthroughs and Value Boundaries[J]. Synthetic Biology Journal, DOI: 10.12211/2096-8280.2025-033.

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, DOI: 10.12211/2096-8280.2025-033.

Figures/Tables 3

Fig. 2 Application scenarios of synthetic biology in medical diagnosis and treatment

Fig. 3 Synthetic biology in the design of chimeric antigen receptors (CAR)a. The basic structure of second-generation CAR, highlighting the critical improvements of costimulatory domains on T cell function.b. An "AND gate" logic recognition system based on synNotch receptors (A AND B).c. An "AND gate" system based on CAR and CCR (chimeric costimulatory receptors).

Fig. 4 Promoting the rapid translation of synthetic biology from laboratory research to diagnostic and therapeutic applications through iterative DBTL (Design–Build–Test–Learn) optimization supported by standardized synthetic biology facility platforms

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