Standardization for biomanufacturing: global landscape, critical challenges, and pathways forward

HUANG Yi; SI Tong; LU Anjing

doi:10.12211/2096-8280.2025-040

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Standardization for biomanufacturing: global landscape, critical challenges, and pathways forward

Invited Review | 更新时间：2025-07-07

- Standardization for biomanufacturing: global landscape, critical challenges, and pathways forward
- Synthetic Biology Journal Vol. 6, Issue 3, Pages: 701-714(2025)
- 作者机构：
  
  1.中国科学院深圳先进技术研究院，定量合成生物学全国重点实验室，深圳合成生物学创新研究院，广东深圳 518055
  2.中国电子信息产业发展研究院，北京 100081
- 作者简介：
- 基金信息：
- DOI：10.12211/2096-8280.2025-040
  CLC： Q81
- Received：29 April 2025，
  
  Revised：2025-06-04，
  
  Published：30 June 2025
- 稿件说明：
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黄怡，司同，陆安静. 生物制造标准体系建设的现状、问题与建议［J］. 合成生物学， 2025， 6（3）： 701-714

HUANG Yi， SI Tong， LU Anjing. Standardization for biomanufacturing： global landscape， critical challenges， and pathways forward［J］. Synthetic Biology Journal， 2025， 6（3）： 701-714
黄怡，司同，陆安静. 生物制造标准体系建设的现状、问题与建议［J］. 合成生物学， 2025， 6（3）： 701-714 DOI： 10.12211/2096-8280.2025-040.

HUANG Yi， SI Tong， LU Anjing. Standardization for biomanufacturing： global landscape， critical challenges， and pathways forward［J］. Synthetic Biology Journal， 2025， 6（3）： 701-714 DOI： 10.12211/2096-8280.2025-040.

摘要

生物制造作为全球科技革命与产业变革的战略制高点，正通过合成生物学和人工智能等前沿技术的深度融合和协同创新，驱动物质生产方式实现颠覆性重塑。生物制造领域的标准化工作是加速科学发现进程、大幅增进生产效能、确保产业健康发展的重要基础。全球主要经济体均已将生物制造标准化列为国家竞争核心要素，竞相争夺产业发展主导权。本文梳理了国内外生物制造领域标准建设现状，从技术研发、产业生态、国际协同三个维度识别出标准制定进程滞后、跨领域标准协同受阻、国际标准互认壁垒三大问题。基于此提出构建动态化标准转化机制、建立跨领域标准协同平台、实施标准国际化计划的标准体系协同发展路径，为我国加快建设生物制造标准体系、推动生物制造从“技术驱动”转向“标准主导”的发展阶段提供理论支撑和决策参考。

Abstract

Biomanufacturing represents a strategic frontier in the global technological revolution and industrial transformation

disruptively reshaping how we produce various products such as biofuels

bioenergy

biobased chemicals

and biomaterials through the convergence of synthetic biology

artificial intelligence

and other cutting-edge technologies. However

the persistent lack of comprehensive standardization frameworks in this emerging field poses significant challenges. Standardization in biomanufacturing is essential for accelerating scientific discovery

enhancing production efficiency

and ensuring sustainable industry growth. Therefore

major global economies have prioritized biomanufacturing standardization as a critical element of national competitiveness. The United States

through the National Institute of Standards and Technology (NIST)

has established itself as a global leader in developing standards for data

metrology

intelligent algorithms

and automated facilities. NIST spearheads numerous ISO standards in biotechnology and biomanufacturing that shape international practices. In the United Kingdom

the Centre for Engineering Biology Metrology and Standards formulates roadmaps to guide the development of metrology and standards for engineering biological species. The European Union fosters the standards in metrology

chassis

yeast

and other eukaryotic systems through the International Cooperation for Synthetic Biology Standardization Project (BioRoBoost). The European Committee for Standardization has been particularly active in developing and updating standards for biomaterials and biobased products including wood-derived products

while establishing corresponding product classification rules. Since launching its 14th Five-Year Plan

China has strategically prioritized the development of standardization for biomanufacturing across the entire value chain

including key components such as sensors

production equipment like bioreactors

and operational processes such as production technical specifications. Furthermore

China has implemented a series of standards for product quality control

testing methods

and evaluation procedures across various biomanufacturing application sectors

including food

pharmaceuticals

fine chemicals

and others. This article presents a comprehensive assessment on the development of biomanufacturing standardization worldwide and in China. At the international level

we focus on standards issued by major international organizations in three major categories: basic commonalities

enabling technologies

and application fields. At the domestic level

our analysis is based on systematic data mining from China Standards Service Network. Our findings reveal several notable patterns. First

the distribution of standard types shows a clear hierarchical structure

with association standards comprising the majority

which highlights the pivotal role of professional organizations in driving technical integration and standardization. Second

we observed substantial variations in standardization maturity across application sectors. Biobased materials currently possess the most comprehensive portfolio with standards for standardization

followed by rapid progress in biobanking and active pharmaceutical ingredient manufacturing. Based on the current status

we identifies major challenges including the lagging of standard formulation

the obstruction of cross-disciplinary standard coordination

and the insufficiency of mutual recognition for international standards

through multi-dimensional analysis encompassing technological development

industrial ecosystem

and international collaboration. To address these challenges

we propose a strategic framework for developing biomanufacturing standards

including the construction of a dynamic standard transformation mechanism

the establishment of a cross-sector standard coordination platform

and the implementation of a standard internationalization plan. These recommendations provide both theoretical foundations and decision-making references for accelerating the development of biomanufacturing standardization system in China. By facilitating the transition from technology-driven to standard-led development in biomanufacturing

this framework aims to help secure China’s competitiveness in the global economy.

关键词

Keywords

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