生物制造标准体系建设的现状、问题与建议

黄怡; 司同; 陆安静

doi:10.12211/2096-8280.2025-040

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生物制造标准体系建设的现状、问题与建议

特约评述 | 更新时间：2025-07-07

- 生物制造标准体系建设的现状、问题与建议
- Standardization for biomanufacturing: global landscape, critical challenges, and pathways forward
- 合成生物学 2025年6卷第3期页码：701-714
- 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：
  
  [ "黄怡（1996—），女，助理研究员。研究方向为生物制造科技情报分析与政策研究。E-mail：y.huang2@siat.ac.cn" ]
  [ "陆安静（1987—），男，副研究员。研究方向为生物制造产业分析、市场与政策研究。E-mail：legendblue@foxmail.com" ]
- 基金信息：
- DOI：10.12211/2096-8280.2025-040
  中图分类号： Q81
- 收稿：2025-04-29，
  
  修回：2025-06-04，
  
  纸质出版：2025-06-30
- 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

references

国家标准化管理委员会 . 标准和标准化 [EB/OL ] . ( 2017-11-06 )[ 2025-06-03 ] . https://www.sac.gov.cn/zt/xxddbzhfzsbb/zswd/art/2017/art_ad543ec72bd24703afd040006805e323.html https://www.sac.gov.cn/zt/xxddbzhfzsbb/zswd/art/2017/art_ad543ec72bd24703afd040006805e323.html .

Standardization Administration of the People’s Republic of China . Standard and standardization [EB/OL ] . ( 2017-11-06 )[ 2025-06-03 ] . https://www.sac.gov.cn/zt/xxddbzhfzsbb/zswd/art/2017/art_ad543ec72bd24703afd040006805e323.html https://www.sac.gov.cn/zt/xxddbzhfzsbb/zswd/art/2017/art_ad543ec72bd24703afd040006805e323.html .

MENG F K , ELLIS T . The second decade of synthetic biology: 2010-2020 [J ] . Nature Communications , 2020 , 11 : 5174 .

赵国屏 . 合成生物学: 开启生命科学“会聚” 研究新时代 [J ] . 中国科学院院刊 , 2018 , 33 ( 11 ): 1135 - 1149 .

ZHAO G P . Synthetic biology: unsealing the convergence era of life science research [J ] . Bulletin of Chinese Academy of Sciences , 2018 , 33 ( 11 ): 1135 - 1149 .

刘陈立 . 拥抱生物经济发展新机遇 [N ] . 经济日报 , 2024-07-05 (10).

LIU C L . Embrace the new opportunities for the development of the bio-economy [N ] . Economic Daily , 2024-07-05 (10).

MEIGE A , EAGAR R , SEHLSTEDT U , et al . The brave new world of synthetic biology: major impacts, significant challenges [R/OL ] . 2024[ 2025-06-03 ] . https://www.adlittle.com/sites/default/files/reports/ADL_BLUE%20SHIFT_Synbio_2024_4.pdf https://www.adlittle.com/sites/default/files/reports/ADL_BLUE%20SHIFT_Synbio_2024_4.pdf .

LUO N , ZHAO G P , LIU C L . Quantitative synthetic biology [J ] . Nature Reviews Bioengineering , 2024 , 2 ( 11 ): 911 - 913 .

MUNSON M , MUNRO S , SALIT M . Synthetic biology standards consortium kick-off workshop report [R ] . U.S. National Institute of Standards and Technology , 2015 .

The White House . National biotechnology and biomanufacturing initiative [EB/OL ] . ( 2022-09-12 )[ 2025-06-03 ] . https://bidenwhitehouse.archives.gov/briefing-room/statements-releases/2022/09/12/fact-sheet-president-biden-to-launch-a-national-biotechnology-and-biomanufacturing-initiative/ https://bidenwhitehouse.archives.gov/briefing-room/statements-releases/2022/09/12/fact-sheet-president-biden-to-launch-a-national-biotechnology-and-biomanufacturing-initiative/ .

THOMAS D . The U.S. biomanufacturing economy: value added, supply chains, cost, sustainability, and efficiency [R/OL ] . National Institute of Standards and Technology , 2023 [ 2025-06-04 ] . https://doi.org/10.6028/NIST.AMS.100-52 https://doi.org/10.6028/NIST.AMS.100-52 .

The White House . U.S. government national standards strategy for critical and emerging technologies (usg nsscet): implementation roadmap [EB/OL ] . ( 2024-07-26 )[ 2025-06-03 ] . https://bidenwhitehouse.archives.gov/wp-content/uploads/2024/07/USG-NSSCET_Implementation_Rdmap_v7_23.pdf https://bidenwhitehouse.archives.gov/wp-content/uploads/2024/07/USG-NSSCET_Implementation_Rdmap_v7_23.pdf .

FREEMONT P S , NI C , AURAND E , et al . Engineering biology metrics and technical standards for the global bioeconomy [R/OL ] . London , UK, 2024 [ 2025-06-03 ] . https://doi.org/10.25561/110822 https://doi.org/10.25561/110822 .

FREEMONT P , ADEOGUN M . Standards and metrics for engineering biology in the UK: driving growth, investment and engineering biology powered solutions for UK companies [R/OL ] . London , UK, 2024 [ 2025-06-03 ] . https://www.npl.co.uk/getattachment/research/biometrology/metrology-for-engineering-biology/resources/Standard-and-metrics-for-Engineering-Biology-in-the-UK.pdf.aspx lang=en-GB https://www.npl.co.uk/getattachment/research/biometrology/metrology-for-engineering-biology/resources/Standard-and-metrics-for-Engineering-Biology-in-the-UK.pdf.aspxlang=en-GB .

ORDOZGOITI E , PORCAR M , BALDWIN G , et al . Standardization in synthetic biology: a white book [R ] . European Union : fostering synthetic biology standardization through international collaboration , 2015 .

European Commission . Building the future with nature: boosting biotechnology and biomanufacturing in the EU [EB/OL ] . ( 2024-03-27 )[ 2025-06-03 ] . https://research-and-innovation.ec.europa.eu/document/download/47554adc-dffc-411b-8cd6-b52417514cb3_en https://research-and-innovation.ec.europa.eu/document/download/47554adc-dffc-411b-8cd6-b52417514cb3_en .

Standard terminology for industrial biotechnology and synthetic biology : ASTM E3072-24 [S/OL ] . [ 2025-06-03 ] . https://store.astm.org/e3072-24.html https://store.astm.org/e3072-24.html .

Biotechnology — Cell counting — Part 1: General guidance on cell counting methods : ISO 20391-1:2018 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/68879.html https://www.iso.org/standard/68879.html .

Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance : ISO 20391-2:2019 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/67892.html https://www.iso.org/standard/67892.html .

陈国强 , 吴赴清 , 郑爽 , 等 . 我国生物制造底盘菌种现状、问题及对策 [J ] . 中国科学院院刊 , 2025 , 40 ( 1 ): 2 - 13 .

CHEN G Q , WU F Q , ZHENG S , et al . Current status and applications of microbial chassis strains for Chinese biomanufacturing industry [J ] . Bulletin of Chinese Academy of Sciences , 2025 , 40 ( 1 ): 2 - 13 .

Microbiology of food and animal feeding stuffs horizontal method for the detection and enumeration of presumptive Escherichia coli-most probable number technique-AMENDMENT 1: inclusion of performance testing of culture media and reagents: ISO 7251:2005/ Amd 1:2023 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/obp/ui/en/#iso:std:iso:7251:ed-3:v1:amd:1:v1:en https://www.iso.org/obp/ui/en/#iso:std:iso:7251:ed-3:v1:amd:1:v1:en .

Biotechnology — Biobanking — General requirements for biobanking : ISO 20387:2018 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/67888.html https://www.iso.org/standard/67888.html .

Biotechnology — Biobanking — Requirements for animal biological material : ISO/TS 20388:2021 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/67889.html https://www.iso.org/standard/67889.html .

Biotechnology — Biobanking — Requirements for the biobanking of plant biological material for research and development : ISO/TS 23105:2021 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/74563.html https://www.iso.org/standard/74563.html .

Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks : ISO 21899:2020 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/72118.html https://www.iso.org/standard/72118.html .

Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow : ISO 24651:2022 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/79141.html https://www.iso.org/standard/79141.html .

Biotechnology — Biobanking — Requirements for human neural stem cells derived from pluripotent stem cells : ISO 18162:2024 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/85207.html https://www.iso.org/standard/85207.html .

Biotechnology — Requirements for data formatting and description in the life sciences : ISO 20691:2022 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/68848.html https://www.iso.org/standard/68848.html .

ROSS D , TONNER P D , VASILYEVA O B . Method for reproducible automated bacterial cell culture and measurement [J ] . Synthetic Biology , 2022 , 7 ( 1 ): ysac013 .

HADDOCK-ANGELLI T , BEAL J , FARNY N , et al . Standard iGEM cell measurement protocol [R/OL ] . ( 2019-07-21 )[ 2025-06-03 ] https://dx.doi.org/10.17504/protocols.io.5nxg5fn https://dx.doi.org/10.17504/protocols.io.5nxg5fn .

Biotechnology — Nucleic acid synthesis — Part 2: Requirements for the production and quality control of synthesized gene fragments, genes, and genomes : ISO 20688-2:2024 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/75852.html https://www.iso.org/standard/75852.html .

中国生物工程学会 . 合成生物学路线图2030:驱动下一代生物制造的引擎 [M ] . 北京 : 科学出版社 , 2024 .

Chinese Society of Biotechnology . Synthetic biology roadmap 2030: the engine driving the next generation of biomanufacturing [M ] . Beijing : Science Press , 2024 .

ROMANTSEVA E , STRYCHALSKI E A . CELL-FREE (Comparable engineered living lysates for research education and entrepreneurship) workshop report [R/OL ] . U.S. National Institute of Standards and Technology , 2020 [ 2025-06-03 ] . https://doi.org/10.6028/NIST.SP.1500-13 https://doi.org/10.6028/NIST.SP.1500-13 .

ROMANTSEVA E . Metrology for cell-free expression systems [R/OL ] .U.S. National Institute of Standards and Technology, 2025 [ 2025-06-03 ] . https://www.nist.gov/programs-projects/metrology-cell-free-expression-systems https://www.nist.gov/programs-projects/metrology-cell-free-expression-systems .

Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — General requirements and definitions — Amendment 1 : ISO 24276:2006/ Amd 1:2013 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/54856.html https://www.iso.org/standard/54856.html .

Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Quantitative nucleic acid based methods — Amendment 1 : ISO 21570:2005/ Amd 1:2013 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/56165.html https://www.iso.org/standard/56165.html .

Bio-based products-Vocabulary: EN 16575:2014 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/cen/111eccbb-b09a-44f6-a6bc-4179d2ee2f16/en-16575-2014 https://standards.iteh.ai/catalog/standards/cen/111eccbb-b09a-44f6-a6bc-4179d2ee2f16/en-16575-2014 .

Rubber and rubber products — Determination of biobased content — Part 3: Biobased mass content : ISO 19984-3:2017 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/66788.html https://www.iso.org/standard/66788.html .

Bio-based products. Bio-based content-Determination of the bio-based content using the material balance method : BS EN 16785-2:2018 [S/OL ] . [ 2025-06-03 ] . https://www.en-standard.eu/bs-en-16785-2-2018-bio-based-products-bio-based-content-determination-of-the-bio-based-content-using-the-material-balance-method/ https://www.en-standard.eu/bs-en-16785-2-2018-bio-based-products-bio-based-content-determination-of-the-bio-based-content-using-the-material-balance-method/ .

Plastics — Biobased content — Part 4: Determination of biobased mass content : ISO 16620-4:2024 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/83892.html https://www.iso.org/standard/83892.html .

Bio-based products-Life Cycle Assessment: EN 16760:2015 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/cen/4344f55a-0c6f-4955-b8e5-f667751d9ac8/en-16760-2015 https://standards.iteh.ai/catalog/standards/cen/4344f55a-0c6f-4955-b8e5-f667751d9ac8/en-16760-2015 .

Bio-based products-Guidelines for Life Cycle Inventory (LCI) for the End-of-life phase: CEN/TR 16957:2016 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/cen/8adb17a6-3c01-48b8-8bb7-ba2f03265ca7/cen-tr-16957-2016 https://standards.iteh.ai/catalog/standards/cen/8adb17a6-3c01-48b8-8bb7-ba2f03265ca7/cen-tr-16957-2016 .

Determination of the ultimate biodegradation of plastics materials in an aqueous system under anoxic (denitrifying) conditions - Method by measurement of pressure increase: EN 17417:2020 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/cen/22abe81e-5e39-4bad-8c1e-82bbf832bd58/en-17417-2020 https://standards.iteh.ai/catalog/standards/cen/22abe81e-5e39-4bad-8c1e-82bbf832bd58/en-17417-2020 .

Plastics-Biodegradable mulch films for use in agriculture and horticulture-Requirements and test methods: EN 17033:2018 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/cen/b09b1982-efd3-45fe-9d87-7798699e5c3c/en-17033-2018 https://standards.iteh.ai/catalog/standards/cen/b09b1982-efd3-45fe-9d87-7798699e5c3c/en-17033-2018 .

Plastics-Determination of the ultimate anaerobic biodegradation of plastic materials in an aqueous system-Method by measurement of biogas production: EN ISO 14853:2017 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/cen/ec5ae8d1-ee89-461c-8392-65de3f07e1f6/en-iso-14853-2017 https://standards.iteh.ai/catalog/standards/cen/ec5ae8d1-ee89-461c-8392-65de3f07e1f6/en-iso-14853-2017 .

Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous medium — Method by measuring the oxygen demand in a closed respirometer : ISO 14851:2019 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/iso/c4cb1c7c-2c9a-4b8f-b10d-f685a1effe59/iso-14851-2019 https://standards.iteh.ai/catalog/standards/iso/c4cb1c7c-2c9a-4b8f-b10d-f685a1effe59/iso-14851-2019 .

Plastics — Evaluation of the action of microorganisms : ISO 846:2019 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/standard/74599.html https://www.iso.org/standard/74599.html .

Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use : ISO 20404:2023 [S/OL ] . [ 2025-06-03 ] . https://cdn.standards.iteh.ai/samples/81477/fadc2bb4791240138cbe44171809445e/ISO-20404-2023.pdf https://cdn.standards.iteh.ai/samples/81477/fadc2bb4791240138cbe44171809445e/ISO-20404-2023.pdf .

Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products : ISO 20399:2022 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/iso/43719c43-d733-43fa-acc3-ad8025ae25ca/iso-20399-2022 https://standards.iteh.ai/catalog/standards/iso/43719c43-d733-43fa-acc3-ad8025ae25ca/iso-20399-2022 .

Biotechnology . Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use : BS PD ISO/TS 23565:2021 [S/OL ] . [ 2025-06-03 ] . https://www.iso.org/obp/ui/en/#iso:std:iso:ts:23565:ed-1:v1:en https://www.iso.org/obp/ui/en/#iso:std:iso:ts:23565:ed-1:v1:en .

Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products : ISO 23033:2021 [S/OL ] . [ 2025-06-03 ] . https://standards.iteh.ai/catalog/standards/iso/46ce33e9-4d64-4d3f-9ada-a500233e3677/iso-23033-2021 https://standards.iteh.ai/catalog/standards/iso/46ce33e9-4d64-4d3f-9ada-a500233e3677/iso-23033-2021 .

Biotechnology — General requirements for transportation of cells for therapeutic use : ISO 21973:2020 [S/OL ] . [ 2025-06-03 ] . https://cdn.standards.iteh.ai/samples/72326/eced53db37d948afaca36690e8153a94/ISO-21973-2020.pdf https://cdn.standards.iteh.ai/samples/72326/eced53db37d948afaca36690e8153a94/ISO-21973-2020.pdf .

中共中央国务院 . 国家标准化发展纲要 [EB/OL ] . ( 2021-10-10 )[ 2025-06-03 ] . https://www.gov.cn/zhengce/2021-10/10/content_5641727.htm https://www.gov.cn/zhengce/2021-10/10/content_5641727.htm .

Central Committee of the Communist Party of China and State Council . National standardization development outline [EB/OL ] . ( 2021-10-10 )[ 2025-06-03 ] . https://www.gov.cn/zhengce/2021-10/10/content_5641727.htm https://www.gov.cn/zhengce/2021-10/10/content_5641727.htm .

工业和信息化部等四部门 . 新产业标准化领航工程实施方案 ( 2023 — 2035 年)[EB/OL ] .( 2023-08-03 )[ 2025-06-03 ] . https://www.gov.cn/zhengce/zhengceku/202308/content_6899527.htm https://www.gov.cn/zhengce/zhengceku/202308/content_6899527.htm .

Ministry of Industry and Information Technology of the People’s Republic of China, Ministry of Science and Technology of the People’s Republic of China, National Energy Administration, et al . Implementation plan for new industry standardization pilot project ( 2023 — 2035 ) [EB/OL ] . ( 2023-08-03 )[ 2025-06-03 ] . https://www.gov.cn/zhengce/zhengceku/202308/content_6899527.htm https://www.gov.cn/zhengce/zhengceku/202308/content_6899527.htm .

工业和信息化部 , 教育部 , 科学技术部 , 等 . 工业和信息化部等七部门关于推动未来产业创新发展的实施意见 [EB/OL ] . ( 2024-01-18 )[ 2025-06-03 ] . https://www.gov.cn/zhengce/zhengceku/202401/content_6929021.htm https://www.gov.cn/zhengce/zhengceku/202401/content_6929021.htm .

Ministry of Industry and Information Technology of the People’s Republic of China , Ministry of Education of the People’s Republic of China , Ministry of Science and Technology of the People’s Republic of China , et al . The guideline to support development of future industries released by the Ministry of Industry and Information Technology and six other ministry and agencies [EB/OL ] . ( 2024-01-18 )[ 2025-06-03 ] . https://www.gov.cn/zhengce/zhengceku/202401/content_6929021.htm https://www.gov.cn/zhengce/zhengceku/202401/content_6929021.htm .

市场监管总局 , 中央网信办 , 国家发展改革委等 18 部门 . 贯彻实施〈国家标准化发展纲要〉行动计划 ( 2024 — 2025 年)[EB/OL ] . ( 2024-03-27 )[ 2025-06-03 ] . https://www.gov.cn/lianbo/bumen/202403/content_6941771.htm https://www.gov.cn/lianbo/bumen/202403/content_6941771.htm .

State Administration for Market Regulation, Office of the Central Cyberspace Affairs Commission, National Development and Reform Commission, et al . Implement the action plan for the implementation of the national standardization development outline ( 2024-2025 )[EB/OL ] . ( 2024-03-27 )[ 2025-06-03 ] . https://www.gov.cn/lianbo/bumen/202403/content_6941771.htm https://www.gov.cn/lianbo/bumen/202403/content_6941771.htm .

国家市场监督管理总局 , 国家标准化管理委员会 . 生物技术生物样本保藏动物生物样本保藏要求 : GB/Z 44314—2024 [S ] . 北京 : 中国标准出版社 , 2024 .

State Administration for Market Regulation , Standardization Administration of the People’s Republic of China . Biotechnology—Biobanking—Requirements for the biobanking of animal biological material : GB/Z 44314—2024 [S ] . Beijing : Standards Press of China , 2024 .

国家市场监督管理总局 , 国家标准化管理委员会 . 生物技术生物样本保藏用于研究和开发用途的植物生物样本保藏要求 : GB/Z 44313—2024 [S ] . 北京 : 中国标准出版社 , 2024 .

State Administration for Market Regulation , Standardization Administration of the People’s Republic of China . Biotechnology—Biobanking—Requirements for the biobanking of plant biological material for research and development : GB/Z 44313—2024 [S ] . Beijing : Standards Press of China , 2024 .

国家市场监督管理总局 , 国家标准化管理委员会 . 人感染病原微生物与样本保藏通用要求 : GB/T 43429—2023 [S ] . 北京 : 中国标准出版社 , 2023 .

State Administration for Market Regulation , Standardization Administration of the People’s Republic of China . General requirements for preservation of human pathogenic microorganisms and samples : GB/T 43429—2023 [S ] . Beijing : Standards Press of China , 2023 .

人胃癌类器官构建、质量控制与保藏: T/1984 CACA 1—2024 [S ] . 北京 : 中国标准出版社 , 2024 .

Human gastric cancer organoid construction, quality control and preservation: T/1984 CACA 1—2024 [S ] . Beijing : Standards Press of China , 2024 .

人肝祖细胞类器官构建、质量控制与保藏操作指南: T/CRHA 017—2023 [S ] . 北京 : 中国标准出版社 , 2023 .

Operational guidelines for construction, quality control and preservation of human liver progenitor cell organoids: T/CRHA 017—2023 [S ] . Beijing : Standards Press of China , 2023 .

人肝胆肿瘤细胞类器官构建、质量控制与保藏操作指南: T/CRHA 018—2023 [S ] . 北京 : 中国标准出版社 , 2023 .

Operational guidelines for construction, quality control and preservation of human hepatobiliary tumor cell organoids: T/CRHA 018—2023 [S ] . Beijing : Standards Press of China , 2023 .

人胆系上皮组织类器官构建、质量控制与保藏操作指南: T/CRHA 019—2023 [S ] . 北京 : 中国标准出版社 , 2023 .

Operational guidelines for construction, quality control and preservation of human biliary epithelial tissue organoids: T/CRHA 019—2023 [S ] . Beijing : Standards Press of China , 2023 .

原料药及中间体连续制造指导原则: T/PIAC 00001—2023 [S ] . 北京 : 中国标准出版社 , 2023 .

Guidelines for continuous manufacturing of drug substances and intermediates: T/PIAC 00001—2023 [S ] . Beijing : Standards Press of China , 2023 .

张春鹏 , 范宇婷 , 董红霞 . 美国新药技术成熟度评价研究 [J ] . 中国药物警戒 , 2020 , 17 ( 6 ): 353 - 356 .

ZHANG C P , FAN Y T , DONG H X . Research on the evaluation method of new drug technology readiness level in the United States [J ] . Chinese Journal of Pharmacovigilance , 2020 , 17 ( 6 ): 353 - 356 .

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