合成生物学赋能特殊医学用途配方食品产业：机遇、挑战与发展路径

丁森; 楼志斌

doi:10.12211/2096-8280.2026-022

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合成生物学赋能特殊医学用途配方食品产业：机遇、挑战与发展路径

观点 | 更新时间：2026-05-12

- 合成生物学赋能特殊医学用途配方食品产业：机遇、挑战与发展路径
- Synthetic biology technology empowering the food for special medical purposes industry： opportunities， challenges， and development pathways
- 合成生物学 2026年页码：1-11
- 作者机构：
  
  上海科学院，上海　201203
- 作者简介：
  
  丁森（1988—），男，助理研究员，博士。研究方向为诊断试剂研发、功能性食品、科技管理等。
  楼志斌（1966—），男，正高级工程师，硕士，硕士生导师。研究方向为科技成果转化、技术标准与创新政策研究，现为上海农业遗传育种重点实验室技术委员会委员，主持多项国防（重大科研）、市科委科研基金项目，在推动相关领域的产业化应用与标准体系建设方面具有重要影响。
- 基金信息：
  
  上海市科技计划项目资助(25692105000)
- DOI：10.12211/2096-8280.2026-022
  中图分类号： Q789;R153;TS202
- 收稿：2026-04-09，
  
  网络首发：2026-05-12，
- 稿件说明：
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丁森，楼志斌. 合成生物学赋能特殊医学用途配方食品产业：机遇、挑战与发展路径［J］. 合成生物学， 2026， 7. DOI： 10.12211/2096-8280.2026-022

DING Sen， LOU Zhibin. Synthetic biology technology empowering the food for special medical purposes industry： opportunities， challenges， and development pathways［J］. Synthetic Biology Journal， 2026， 7. DOI： 10.12211/2096-8280.2026-022
丁森，楼志斌. 合成生物学赋能特殊医学用途配方食品产业：机遇、挑战与发展路径［J］. 合成生物学， 2026， 7. DOI： 10.12211/2096-8280.2026-022 DOI：

DING Sen， LOU Zhibin. Synthetic biology technology empowering the food for special medical purposes industry： opportunities， challenges， and development pathways［J］. Synthetic Biology Journal， 2026， 7. DOI： 10.12211/2096-8280.2026-022 DOI：

摘要

在全球科技革命与产业变革加速演进的背景下，合成生物学作为一门融合生命科学、工程学与信息科学的前沿交叉技术，展现出强大的“创造性破坏”潜力，为生命健康产业带来了范式革命。特殊医学用途配方食品（简称“特医食品”）作为满足特定疾病状态人群营养需求的特殊食品，其产业发展需要在原料生产、配方设计、生产模式、产业逻辑和商业模式等方面进行系统性重塑。本文以合成生物学赋能特医食品产业为典型案例，通过文献综述、案例研究、调研访谈等方法，深入剖析合成生物学技术赋能特医用食品产业面临的现实挑战以及蕴含的战略机遇，并从强化核心技术攻关、优化创新生态系统、完善政策与监管体系等方面提出对策建议。为合成生物学驱动特医食品产业高质量发展、实现技术可行到产业可用的跨越提供理论参考与路径支撑。

Abstract

Under the accelerating wave of global technological revolution and industrial transformation

synthetic biology has emerged as a cutting-edge interdisciplinary field integrating life sciences

engineering

and information sciences. Its "creative destruction" potential is reshaping the landscape of life and health industries. Foods for Special Medical Purposes (FSMPs) are specially processed and formulated to meet the unique nutritional needs of individuals with restricted eating

digestive or absorption disorders

metabolic disturbances

or other specific disease conditions. Beyond serving as a critical vehicle for clinical nutrition support

proactive health intervention

and the silver economy

FSMPs represent a systemic solution to improve clinical outcomes

reduce healthcare costs

and enhance quality of life. This study takes synthetic biology-empowered FSMPs as a typical case to systematically explore the opportunities

challenges

and development pathways. Through literature review

case studies

and research interviews

the paper analyzes how synthetic biology can fundamentally reshape FSMP industry in terms of raw material production

formula design

manufacturing models

industrial logic

and business models. The findings show that synthetic biology

following the “Design-Build-Test-Learn (DBTL)” paradigm

has enabled efficient biosynthesis of human milk oligosaccharides (HMOs)

functional proteins

novel lipids

vitamins

and other high-value ingredients via enzymatic conversion

whole-cell catalysis

and microbial fermentation. Despite these advances

the transition from laboratory feasibility to industrial-scale application faces three major gaps: engineering scale-up instability

market cost and acceptance barriers

and regulatory approval uncertainties. To systematically address these challenges

the study proposes a coordinated governance model integrating technology

regulation

market

and ecosystem. The study concludes that synthetic biology holds transformative potential to drive the FSMP industry toward a new phase of precision

accessibility

and sustainability. However

breakthroughs in single dimensions are insufficient; multi-stakeholder coordination is essential to move from “technologically feasible” to “industrially viable

clinically accessible

and market-trusted.” The findings provide strategic pathways for leveraging synthetic biology to support high-quality development of the FSMP industry under China's 15th Five-Year Plan and the Healthy China initiative.

关键词

Keywords

references

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