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Article(id=1211302344810173263, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1211302341744137007, articleNumber=null, orderNo=17, doi=10.3981/j.issn.1000-7857.2025.09.00034, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1757001600000, receivedDateStr=2025-09-05, revisedDate=1763395200000, revisedDateStr=2025-11-18, acceptedDate=1763481600000, acceptedDateStr=2025-11-19, onlineDate=1766726583911, onlineDateStr=2025-12-26, pubDate=1765555200000, pubDateStr=2025-12-13, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1767456000000, onlineIssueDateStr=2026-01-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1766726583911, creator=13701087609, updateTime=1774080372007, updator=sys-migrate, issue=Issue{id=1211302341744137007, tenantId=1146029695717560320, journalId=1146031591421210625, year='2025', volume='43', issue='23', pageStart='1', pageEnd='112', issueExtLink='null', onlineDate='null', pubDate='1765555200000', pubDateStr='2025-12-13', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1766726583181, creator='13701087609', updateTime=1774330548003, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1243195681876328676, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1211302341744137007, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1243195681876328677, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1211302341744137007, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=33, endPage=39, ext={EN=ArticleExt(id=1211302345128940381, articleId=1211302344810173263, tenantId=1146029695717560320, journalId=1146031591421210625, language=EN, title=Synthetic biological manufacturing of pharmaceuticals, columnId=1150494642224591153, journalTitle=Science & Technology Review, columnName=Exclusive, runingTitle=null, highlight=null, articleAbstract=

China's pharmaceutical industry has made remarkable progress in development, yet it also faces significant challenges in technological innovation and industrial upgrading. This paper provides a systematic overview of the technological architecture underlying synthetic biomanufacturing, highlighting its core advantages grounded in the use of renewable feedstocks, environmentally benign processes, and superior atom economy. On this basis, the paper offers an in−depth discussion of the innovative applications and recent advancements of synthetic biomanufacturing in the synthesis of chemical active pharmaceutical ingredients, bioactive constituents of modernized traditional Chinese medicine, and macromolecular therapeutics including proteins and antibodies. Despite its promising outlook, the field still faces key constraints such as suboptimal technology translation efficiency, barriers to interdisciplinary integration, and limited end−to−end process consolidation across the value chain. To overcome these limitations, it is imperative to strengthen AI−enabled enzyme engineering and metabolic pathway optimization, while promoting deeper convergence with materials science, chemical engineering, and related disciplines to establish next−generation biomanufacturing platforms. In conclusion, synthetic biomanufacturing represents both a strategic driver and an indispensable pathway for advancing China's pharmaceutical industry toward greater precision, efficiency, and intelligence, thereby reinforcing its global competitiveness.

, authors=null, authorsList=Xiaoling TANG, Jucan GAO, Renchao ZHENG, Yuguo ZHENG, authorCompany=null, correspAuthors=Yuguo ZHENG, authorNote=null, correspAuthorsNote=null, copyrightStatement=All rights reserved. Unauthorized reproduction is prohibited., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1211302345888109452, articleId=1211302344810173263, tenantId=1146029695717560320, journalId=1146031591421210625, language=CN, title=医药合成生物制造, columnId=1150494642375586098, journalTitle=科技导报, columnName=特色专题, runingTitle=null, highlight=null, articleAbstract=

中国医药工业发展取得巨大进步，但也面临技术革新和产业升级的重大挑战。综述了合成生物制造技术体系，重点剖析了其以可再生原料、绿色工艺与原子经济性为核心的显著优势。在此基础上，详细阐述了合成生物制造在化学原料药、现代中药活性成分及蛋白、抗体等大分子药物合成中的创新应用与实践进展。尽管该领域前景广阔，但仍存在技术转化效率不足、跨学科协同壁垒及全链条整合度不高等关键问题。为此，应加强人工智能辅助的酶设计与代谢路径优化，并深化与材料、工程等学科的融合，以构建新一代生物制造技术平台。总之，合成生物制造是推动中国医药工业迈向更精准、高效、智能发展，构筑全球核心竞争力的关键引擎与必然路径。

, authors=

汤晓玲，教授，研究方向为生物催化转化，电子信箱：

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郑裕国（通信作者），教授，中国工程院院士，研究方向为医药、农药和营养化学品生物制造工程技术创新，电子信箱：
, copyrightStatement=版权所有，未经授权，不得转载。, copyrightOwner=《科技导报》编辑部, extLink=null, articleAbsUrl=null, sourceXml=ek6ZYFbtSZGqzfS8ww+bmA==, magXml=ek6ZYFbtSZGqzfS8ww+bmA==, pdfUrl=null, pdf=Gw+KH6q3eZyXQeHkh+tPjA==, pdfFileSize=1466985, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=yNbZvfMowVimeSVUWpRgAw==, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=mVFxM7Ws8bOGmGdTSiP4EA==, mapNumber=null, fund=null)}, authors=[Author(id=1242146378999210184, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1211302344810173263, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=tangxl@zjut.edu.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1242146379087290571, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1211302344810173263, authorId=1242146378999210184, language=EN, stringName=Xiaoling TANG, firstName=Xiaoling, middleName=null, lastName=TANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1College of Biotechnology and Bioengineering, Zhejiang University of Technology, Hangzhou 310014, China
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医药合成生物制造
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汤晓玲 1, 2 , 高炬灿 1 , 郑仁朝 1, 2 , 郑裕国 1, 2, *
科技导报 | 特色专题 2025,43(23): 33-39
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科技导报 |特色专题 2025 , 43 (23) : 33 -39
医药合成生物制造
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汤晓玲1, 2 , 高炬灿1, 郑仁朝1, 2, 郑裕国1, 2, *
作者信息
  • 1浙江工业大学生物工程学院，杭州 310014
  • 2绿色化学合成与转化技术全国重点实验室，杭州 310014
通讯作者:
郑裕国（通信作者），教授，中国工程院院士，研究方向为医药、农药和营养化学品生物制造工程技术创新，电子信箱：
Synthetic biological manufacturing of pharmaceuticals
Xiaoling TANG1, 2 , Jucan GAO1, Renchao ZHENG1, 2, Yuguo ZHENG1, 2, *
Affiliations
  • 1College of Biotechnology and Bioengineering, Zhejiang University of Technology, Hangzhou 310014, China
  • 2State Key Laboratory of Green Chemical Synthesis and Transformation Technology, Hangzhou 310014, China
出版时间: 2025-12-13 doi: 10.3981/j.issn.1000-7857.2025.09.00034
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摘要
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中国医药工业发展取得巨大进步，但也面临技术革新和产业升级的重大挑战。综述了合成生物制造技术体系，重点剖析了其以可再生原料、绿色工艺与原子经济性为核心的显著优势。在此基础上，详细阐述了合成生物制造在化学原料药、现代中药活性成分及蛋白、抗体等大分子药物合成中的创新应用与实践进展。尽管该领域前景广阔，但仍存在技术转化效率不足、跨学科协同壁垒及全链条整合度不高等关键问题。为此，应加强人工智能辅助的酶设计与代谢路径优化，并深化与材料、工程等学科的融合，以构建新一代生物制造技术平台。总之，合成生物制造是推动中国医药工业迈向更精准、高效、智能发展，构筑全球核心竞争力的关键引擎与必然路径。

医药工业  /  合成生物制造  /  生物催化  /  细胞工厂  /  绿色制造

China's pharmaceutical industry has made remarkable progress in development, yet it also faces significant challenges in technological innovation and industrial upgrading. This paper provides a systematic overview of the technological architecture underlying synthetic biomanufacturing, highlighting its core advantages grounded in the use of renewable feedstocks, environmentally benign processes, and superior atom economy. On this basis, the paper offers an in−depth discussion of the innovative applications and recent advancements of synthetic biomanufacturing in the synthesis of chemical active pharmaceutical ingredients, bioactive constituents of modernized traditional Chinese medicine, and macromolecular therapeutics including proteins and antibodies. Despite its promising outlook, the field still faces key constraints such as suboptimal technology translation efficiency, barriers to interdisciplinary integration, and limited end−to−end process consolidation across the value chain. To overcome these limitations, it is imperative to strengthen AI−enabled enzyme engineering and metabolic pathway optimization, while promoting deeper convergence with materials science, chemical engineering, and related disciplines to establish next−generation biomanufacturing platforms. In conclusion, synthetic biomanufacturing represents both a strategic driver and an indispensable pathway for advancing China's pharmaceutical industry toward greater precision, efficiency, and intelligence, thereby reinforcing its global competitiveness.

pharmaceutical industry  /  synthetic biological manufacturing  /  biocatalysis  /  microbial cell factory  /  green manufacturing
汤晓玲, 高炬灿, 郑仁朝, 郑裕国. 医药合成生物制造. 科技导报, 2025 , 43 (23) : 33 -39 . DOI: 10.3981/j.issn.1000-7857.2025.09.00034
Xiaoling TANG, Jucan GAO, Renchao ZHENG, Yuguo ZHENG. Synthetic biological manufacturing of pharmaceuticals[J]. Science & Technology Review, 2025 , 43 (23) : 33 -39 . DOI: 10.3981/j.issn.1000-7857.2025.09.00034
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医药产业面向国家重大需求，面向人民生命健康，直接关系国计民生，是衡量一个国家科技创新能力和综合国力的重要标志之一。医药制造业作为医药产业的核心支撑，涵盖原料药、药物中间体、辅料、制剂等关键环节的制造及相关领域，其发展深度融合生物工程、化学工程、材料工程、控制工程等多学科专业，构成了医药产业高质量发展的坚实基础[1]。
经过数十年的快速发展，中国已成为全球最大的医药生产基地，产能占比高达40%，为全球医药供应链的稳定提供了重要保障。然而，在规模扩张的背后，医药制造业正面临着前所未有的挑战。一方面，恶性肿瘤、心脑血管疾病、神经退行性疾病、糖尿病、自身免疫性疾病等重大疾病的发病率持续攀升，对药物的种类、疗效和可及性提出了更为迫切的需求。另一方面，新的市场竞争格局与外部不确定性因素，要求行业在成本控制、质量提升、工艺优化等方面不断取得突破[2−3]。传统医药制造存在反应步骤繁琐、原料利用率低、环境污染严重等问题，且难以满足复杂结构药物的高效生产需求，成为制约产业高质量发展的瓶颈。
在此背景下，合成生物制造作为一种颠覆性前沿技术，正逐渐成为驱动医药工业变革的“绿色动力”，催生新产业、创建新模式、形成新动能，实现从资源分子向功能分子、再向功能产品的精准转化，更大程度发挥原子经济性[4]。合成生物制造融入医药制造过程将形成新的工业体系，推动医药产业的高质量发展，促进产业的升级，是实现“碳达峰、碳中和”与“健康中国2030”等国家战略的重要突破口[5]。
1 合成生物制造及其优势
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近年来，合成生物学迅猛发展，已成为全球科技竞争的新高地，在医药、农药、食品、材料等关键领域展现出颠覆性潜力[6]。合成生物学是指采用工程化设计理念，对生物体的遗传物质、代谢路径、调控网络等进行定向设计、精准改造、重新编程乃至从头合成，从而突破自然生命固有的进化规律和功能限制，重塑自然生产线，其目标直指物质的高效定向合成与精准转化。合成生物制造则是以多学科交叉融合为手段，改造或创造具有特定功能的生物体或其组分，通过过程和系统强化实现物质的高效合成与精准转化，再造产品大规模生产流程，创造经济价值和社会效益的未来产业。
合成生物制造正成为先进制造业的核心构成，对塑造新发展格局具有重要意义。2024年，合成生物学技术引领的市场规模达190亿美元，年复合增长率为28.4%。据预测，到21世纪末，合成生物制造有望创造数十万亿美元的经济价值。与石化路线相比，合成生物制造产品平均节能减排30%~50%，且未来潜力有望突破70%[7]。以工业催化剂为例，全球至少有4.2万种原料和化学中间体依赖催化剂直接或间接合成，其中许多贵金属和非贵金属催化剂来自矿产，属于不可再生资源，且开采成本高。以可再生、可降解的蛋白质为生物催化剂替代化学催化剂，既实现催化剂原料的替代，又实现绿色低碳生产。例如，在丙烯酰胺工业生产中，以腈水合酶替代骨架铜催化剂，降低反应能耗、减少副产物，其聚合物广泛用于水处理、石油开采等行业[8]。此外，通过构建高效细胞工厂，可实现复杂化合物的精准合成与规模化生产。例如，在抗生素、甾体类药物[9−10]等的生产中，通过动态调控细胞工厂代谢流、优化关键酶表达等方法，实现了目标产物的定向积累，展现出合成生物制造在药物合成领域从“实验室创新”到“工业化应用”的巨大潜力。
药品作为调节生理机能的特殊商品，在预防、治疗、诊断人类疾病中发挥着不可替代的作用。随着国际医药市场竞争日趋激烈，对药品生产的要求越来越高，即品质更好、价格更低、可及性更高。合成生物制造既能为创新药研发注入强劲动力，又能推动仿制药产业提质降价。在创新药领域，合成生物制造借助基因编辑、代谢通路重构等技术，能够突破天然产物提取的局限，发现并高效合成具有全新结构的化合物，具备更精准的靶向性和更强的生理活性，为恶性肿瘤、自身免疫性疾病等重大疾病的治疗带来新突破。而在仿制药领域，合成生物制造通过革新生产工艺，以生物合成替代传统化学合成，不仅能严格控制产品纯度和杂质含量，确保仿制药与原研药在质量和疗效上的一致性，还能摆脱对昂贵化学原料和复杂反应条件的依赖，大幅降低生产成本[11]。
2 医药的合成生物制造
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2.1 化学药的合成生物制造
2.1.1 生物催化合成医药化学品
化学药物分子趋于复杂，光学纯度要求高，传统合成过程需要连续保护/去保护，反应步骤多，收率低，越来越难以满足先进制造要求。合成生物制造通过药物合成途径设计、催化剂筛选和适应性改造、催化体系构建调控，实现药物的高效合成（图1）。相较于传统化学合成，合成生物制造利用酶高度化学、区域和立体选择性，能够突破复杂分子精准合成、手性中心精准构筑等技术瓶颈，为众多复杂结构药物的规模化生产提供了可行路径[12]。
随着生物技术和蛋白质工程技术的飞速发展，在酶的精准调控方面，借助人工智能（artificial intelligence，AI）辅助的理性设计，可突破传统方法仅对酶分子结构进行微小扰动的局限，迈向基于计算设计的活性位点大范围协同突变，从而显著提升酶的催化效率、选择性、稳定性等催化属性。在催化剂固定化领域，新型载体材料与固定化工艺的结合，不仅解决了游离酶回收难、稳定性差的问题，更实现了酶的重复利用与反应体系的连续化操作，大幅降低了工业化应用成本。而在催化过程智能控制方面，耦合生物传感器与自动化反应装置的动态调控系统，可实时监测底物消耗、产物生成及关键代谢物浓度，通过算法模型精准调节反应温度、pH值等参数，优化催化过程。这些技术突破持续拓展着生物催化的应用边界，为其在医药合成领域的规模化、精准化应用奠定了坚实基础。如第三代他汀类药物（阿托伐他汀、瑞舒伐他汀等）具有理想的降脂效果，半衰期长，对肝脏、肾脏毒性更小，是预防和治疗高血脂症的首选药物。该类他汀含有以手性二醇结构为主要药效团的通用侧链。由于手性二醇侧链中含有2个手性羟基，可生成4个差向异构体，手性中心的构筑难度极高。随着生物催化技术的发展，创制新型羰基还原酶和卤醇脱卤酶，重构了第三代他汀关键合成步骤，在温和反应条件下，成功构建了手性二醇侧链的2个手性中心。在此基础上，偶联化学催化单元，实现了阿托伐他汀、瑞舒伐他汀的高效制造[13]。
γ−氨基丁酸（γ−aminobutyric acid，GABA）类药物能够跨越血脑屏障，通过调节神经递质的释放，维持脑内兴奋性递质与抑制性递质的平衡，是治疗神经退行性疾病的重大品种。化学法是合成GABA类药物的传统方法，但存在路线冗长、原子经济性不高等缺点。基于有机逆合成分析，构建了腈水解酶区域、立体选择性水解2−取代丁二腈及催化加氢合成GABA类药物的新路线[14]。未反应的底物异构体通过原位消旋实现动态动力学拆分，打破动力学拆分理论产率仅有50%的局限，显示出巨大的工业化潜力。
近年来，多酶级联催化通过酶元件创制、多酶复合体设计与组装调控构建崭新的医药化学品人工生物合成途径[15−16]。与酶催化或全细胞催化相比，多酶级联合成既规避了细胞内复杂代谢网络的干扰，又实现了多步反应的连续转化，为高附加值药物分子的绿色合成提供了途径[17]。例如，核苷型类似物伊拉曲韦（Islatravir）是一种人类免疫缺陷病毒（human immunodeficiency virus，HIV）逆转录酶易位抑制剂，有望用于HIV暴露前的预防感染，降低治疗的给药频率。由于涉及多步保护/去保护反应的活性基团，化学法合成伊拉曲韦需要长达12~18步的反应。研究者在细菌核苷补救途径的启发下，设计了一条无需保护/去保护反应的伊拉曲韦的多酶生物合成路线。该方法以2−乙炔基甘油为原料，通过脱氧核糖5−磷酸醛缩酶、磷酸突变酶、嘌呤核苷磷酸化酶和多种辅助酶驱动反应，伊拉曲韦总收率达51%[18]。
2.1.2 微生物细胞工厂合成医药化学品
微生物是药物的重要来源（如抗生素、免疫调节剂、酶抑制剂、抗肿瘤药物等），微生物发酵是部分药物的唯一生产方法。但是，传统微生物发酵存在代谢过程复杂、竞争旁路多、结构类似组分多等问题，导致发酵效价低，产物分离困难。微细胞工厂构建通过基因编辑、代谢网络重构、调控元件优化等手段，对微生物（如大肠杆菌、酵母菌、放线菌等）进行定向改造，使其成为可高效合成目标医药化学品的微型生产单元，其核心在于优化天然存在的生物合成途径或人工设计非天然代谢通路。进一步通过强化目标产物合成关键酶、解除代谢抑制、消除副产物分流等，实现医药化学品的从头合成或半合成[19−20]，从而突破传统提取法对天然资源的依赖及化学合成法的工艺局限（图2）。
细胞工厂构建技术在精准设计与高效优化方面持续突破。在全细胞精准模型构建方面，基于多组学数据（基因组、转录组、代谢组等）与机器学习算法的整合分析，已实现对底盘细胞代谢网络的动态模拟与定量预测。通过构建包含上千个代谢反应的全细胞数学模型，可精准计算不同培养条件下碳源分配、辅酶平衡及能量代谢的动态变化，指导关键节点酶的表达强度调控与代谢流定向分配。大片段基因编辑技术的成熟则大幅提升了细胞工厂的构建效率，可实现外源基因簇的精准整合与底盘基因组的大片段删除，解决了传统方法在复杂通路组装中的效率局限[21]。细胞适应性进化则通过模拟自然选择压力（如底物胁迫、产物毒性、营养限制等），驱动细胞在长期传代中积累有益突变，从而增强其工业适配性[22]。以上技术推动微细胞工厂从“可合成”向“高效合成、稳定生产”跨越，为医药化学品的工业化放大提供了关键技术保障。
以抗肿瘤药物紫杉醇的合成为例，传统提取法依赖红豆杉树皮，每吨树皮仅能提取0.5~1.0 g紫杉醇，而化学全合成因步骤繁琐、收率极低而难以工业化。研究者以酿酒酵母为底盘细胞，通过异源表达红豆杉来源的紫杉二烯合成酶、紫杉烯5α−羟化酶等关键酶基因，同时引入代谢调控元件优化前体物质（如异戊烯基焦磷酸）的供给通量等，成功重构了紫杉醇的完整生物合成通路。为解决异源酶活性低、中间产物毒性积累等问题，进一步通过规律成簇间隔短回文重复序列及其关联蛋白9（Clustered Regularly Interspaced Short Palindromic Repeats−associated protein 9，CRISPR−Cas9）介导的基因组定点整合技术优化酶表达量，结合动态传感器调控系统实时平衡代谢流，使酵母细胞工厂的紫杉醇产量提升至1.0 mg/L，较早期工程菌株提高近百倍[23−24]。在此基础上，通过耦合甲基转移酶等关键酶的定向改造，实现了紫杉醇侧链的胞内修饰，构建完整的紫杉醇合成体系，大幅缩短生产周期，降低了对珍稀植物资源的依赖[25]。
两性霉素是由结节链霉菌产生的一种多烯大环内酯类抗生素，具有重要的广谱抗真菌作用，广泛用于全身性真菌感染的治疗。建立了两性霉素B抑菌圈高通量筛选方法，筛选效率提升50倍。进一步通过复合诱变，筛选到两性霉素B合成显著提升的结节链霉菌，利用多组学技术结合反向代谢工程解析菌株高产机制，并通过定量表达和定点改造关键合成酶，完全消除副产物两性霉素A的合成。在此基础上，结合代谢网络分析及发酵过程调控，建立了精准发酵调控工艺，使两性霉素B合成效率提高了85.9%，产量达18.39 g/L，同时发酵周期较原始菌株大幅降低[26]。
2.2 现代中药的合成生物制造
中药以天然动植物、矿物等为主要来源，经传统炮制工艺加工或配伍而成，是中国独具特色的医药卫生资源。随着需求扩张与环境变化，传统中药采集问题逐渐凸显。无序采挖导致资源枯竭，野生种群濒临灭绝，破坏了生态平衡与药材自然再生能力。此外，无序采集收率低、生产成本高，产品质量不均一。合成生物制造基于培养条件模拟和多组学分析，明确灵芝、冬虫夏草、茯苓等中药生产菌株遗传背景、代谢特征，发挥液体深层发酵等技术优势，实现中药的现代化高效生产。
发酵调控作为合成生物制造工业化生产的核心支撑技术，是指通过对发酵过程关键参数的动态监测与系统优化，以实现细胞工厂高效、稳定生产目标产物的技术体系[27]。随着研究的深入，基于发酵过程中细胞代谢的动态特性，研究者开发了红外在线传感、拉曼光谱在线监测等先进检测技术，可实时追踪代谢体系的关键参数（如底物消耗速率、产物积累量、细胞活性等），通过构建以细胞代谢网络模型为核心、耦合关键代谢物在线检测的全方位监测体系，推动动态精准调控策略的实施。此外，过程机理模型的建立实现了对代谢产物合成规律的深度解析。通过解析发酵动态特征与营养基质（碳氮源比例、微量元素浓度等）、环境因子（溶氧量、搅拌速率、剪切力等）的关联机制，可精准预测不同条件对产物合成的影响[28−29]。以上技术不仅显著降低了发酵过程的能耗、物耗，更打破了传统经验化放大技术的效率瓶颈，使生物反应器的放大倍数从十倍级跃升至千倍级，为中药的工业化量产提供了高效、稳定的工程化解决方案。
冬虫夏草作为传统名贵中药材，仅存在于中国青海、四川、西藏等海拔3500~5000 m地区，对温度、湿度、含氧量等因素有特殊要求。研究者基于微生物生长、形态、代谢特征分析，分离得到的中国被毛孢（Hirsutella sinensis），是仅存在于冬虫夏草中的唯一无性型。研究表明，冬虫夏草的主要活性成分来源于该菌株。依托微生物发酵技术，以中国被毛孢为发酵菌株，通过优化培养基配方和发酵参数，模拟冬虫夏草天然生长的微生态环境，引导菌株定向合成目标活性成分。同时，采用发酵过程动态调控策略——通过在线监测菌丝体浓度、胞外多糖含量及关键酶活变化，实时调整搅拌速率与补料节奏，有效解决了深层液体发酵中菌丝体结团、传质效率低等问题，显著提升了活性成分的累积效率。为阐明发酵产物的药用价值，研究者结合高通量测序解析中国被毛孢的基因组与转录组特征，通过代谢组学分析比对发酵产物与野生冬虫夏草的化学指纹图谱，证实两者在虫草素、虫草酸、虫草多糖、腺苷等核心活性成分的种类及含量上高度一致。在此基础上，建立了标准化的工业化生产流程，不仅缓解了野生资源的采收压力，更通过稳定的质量控制与规模化生产，保障了冬虫夏草用药需求[30−31]。
复方丹参制剂是治疗冠心病和心绞痛的常用中药复方，主要由丹参、三七和冰片组成。研究者通过对中药活性成分异源合成，首次在单一酿酒酵母细胞中并行重构了三七皂苷前体原人参二醇、丹参酮前体次丹参酮二烯以及冰片这3类不同物种来源的代谢途径，构建了“复方丹参酵母1.0”。通过构建的萜类合酶筛选框架，鉴定出一种新型高效磷酸硼酸酯合酶，实现了关键合成元件的挖掘与适配。该工程菌在摇瓶发酵中可使原人参二醇产量达到62.34 mg/L，次丹参酮二烯产量达到15.38 mg/L，冰片产量达到2.54 mg/L。该工作首次实现了跨物种、多组分中药复方的合成生物学仿生合成，为中药复方的绿色智能制造与资源可持续利用奠定了技术基础[32]。
2.3 大分子药物的合成生物制造
大分子药物如蛋白、多肽、核酸药物等，由于结构的复杂性与生物活性的高度依赖性，其合成面临多重挑战，精准构筑难度大。随着基因工程技术、重组细胞高效表达技术等的不断成熟和发展，大分子药物研发周期缩短。通过理性设计基因序列，可对抗体、多肽等大分子的靶向结构域进行定向改造，结合重组蛋白的翻译后修饰，可提高大分子药的特异性和靶向性，利用CRISPR−Cas9等技术可精准改造宿主细胞的代谢通路，快速构建高产工程菌株或细胞系，实现目标产物的高效、稳定表达。
胰高血糖素样肽−1（Glucagon−Like Peptide−1，GLP−1）受体激动剂多肽药物在治疗II型糖尿病中具有重要应用，可以解除和控制糖尿病患者经常出现的低血糖、高血压、体重失控等病症。化学合成复杂长链GLP−1多肽时，随着氨基酸数量增多，反应步骤呈指数级增长，副反应多，产物纯度与收率急剧下降，难以实现高效率生产。通过基因编辑技术，能够精准设计编码GLP−1多肽的基因序列，通过优化密码子，提升在宿主细胞（如大肠杆菌）内的转录与翻译效率，可将表达量提升数倍。同时，利用合成生物学构建的新型宿主细胞，可有效规避多肽被蛋白酶降解的问题。通过基因敲除技术，敲除宿主细胞内降解多肽的关键蛋白酶基因，或者导入能够抑制蛋白酶活性的基因元件，确保GLP−1多肽在细胞内稳定表达与积累。凭借其显著的疗效与不断拓展的适应症，GLP−1受体激动剂在全球范围内形成了巨大的市场规模，2024年全球市场规模已达到518亿美元。
重组人胰岛素是治疗糖尿病的关键药物，可以通过多种途径降低血糖，为糖尿病患者维持正常代谢提供关键支持。研究者开发了基于荧光假单胞菌的新型微生物细胞工厂来合成胰岛素，以替代传统的大肠杆菌表达系统。通过将优化后的人胰岛素基因导入荧光假单胞菌，实现了目标蛋白的高效可溶性表达，显著减少了传统系统中常见的包涵体形成问题。进一步通过系统优化发酵条件，并结合建立的动力学模型精准模拟与指导发酵过程，使蛋白产率提高了48%，达到214.7 mg/L。该工艺成功证明了荧光假单胞菌作为工业化生产胰岛素和其他复杂重组蛋白平台的巨大潜力与优势[33]。
3 结论与展望
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合成生物制造通过生物催化、多酶级联、细胞工厂构建及微生物发酵等核心技术的创新应用，已在医药化学品合成领域展现出显著优势，突破了传统化学合成步骤繁琐、污染严重等局限，克服了天然产物提取对资源的依赖，为医药产业绿色化、高效化、可持续化发展提供了核心驱动力，强有力地推动了医药产业的转型升级。展望未来，合成生物制造在医药领域的应用将朝着更精准、更高效、更智能的方向迈进。一方面，随着AI辅助设计、高通量筛选、动态代谢调控等技术的深度融合，酶的催化效率、细胞工厂的产物合成能力将持续突破[34]，推动更多高难度医药化学品实现工业化生产；另一方面，跨学科交叉融合将加速实验室创新向产业级应用的转化，进一步降低生产成本、提升产品质量。合成生物制造将重塑医药产业格局，为人类健康事业与可持续发展贡献更大力量。
基金
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  • 国家重点研发计划项目(2021YFA1501400)
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2025年第43卷第23期
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doi: 10.3981/j.issn.1000-7857.2025.09.00034
  • 接收时间：2025-09-05
  • 首发时间：2025-12-26
  • 出版时间：2025-12-13
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  • 收稿日期：2025-09-05
  • 修回日期：2025-11-18
  • 录用日期：2025-11-19
基金
国家重点研发计划项目(2021YFA1501400)
作者信息
    1浙江工业大学生物工程学院，杭州 310014
    2绿色化学合成与转化技术全国重点实验室，杭州 310014

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郑裕国（通信作者），教授，中国工程院院士，研究方向为医药、农药和营养化学品生物制造工程技术创新，电子信箱：
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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