• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

比较疫苗制造技术：重组 DNA 与体外转录（IVT）mRNA。

COMPARING vaccine manufacturing technologies recombinant DNA vs in vitro transcribed (IVT) mRNA.

机构信息

Department of Chemical Engineering, Aristotle University of Thessaloniki, 54124, Thessaloniki, Greece.

Department of Clinical Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.

出版信息

Sci Rep. 2024 Sep 18;14(1):21742. doi: 10.1038/s41598-024-67797-x.

DOI:10.1038/s41598-024-67797-x
PMID:39289418
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11408659/
Abstract

Vaccine manufacturing fosters the prevention, control, and eradication of infectious diseases. Recombinant DNA and in vitro (IVT) mRNA vaccine manufacturing technologies were enforced to combat the recent pandemic. Despite the impact of these technologies, there exists no scientific announcement that compares them. Digital Shadows are employed in this study to simulate each technology, investigating root cause deviations, technical merits, and liabilities, evaluating cost scenarios. Under this lens we provide an unbiased, advanced comparative technoeconomic study, one that determines which of these manufacturing platforms are suited for the two types of vaccines considered (monoclonal antibodies or antigens). We find recombinant DNA technology to exhibit higher Profitability Index due to lower capital and starting material requirements, pertaining to lower Minimum Selling Price per Dose values, delivering products of established quality. However, the potency of the mRNA, the streamlined and scalable synthetic processes involved and the raw material availability, facilitate faster market penetration and product flexibility, constituting these vaccines preferable whenever short product development cycles become a necessity.

摘要

疫苗制造促进了传染病的预防、控制和消除。为了应对最近的大流行，采用了重组 DNA 和体外（IVT）mRNA 疫苗制造技术。尽管这些技术产生了影响，但目前还没有对它们进行比较的科学公告。本研究采用数字阴影来模拟每种技术，研究根本原因偏差、技术优点和缺点，并评估成本方案。在此视角下，我们提供了一种公正、先进的技术经济比较研究，确定了这些制造平台中哪些适合考虑的两种疫苗（单克隆抗体或抗原）。我们发现，由于较低的资本和起始材料要求，与较低的每剂量最低销售价格相关，重组 DNA 技术表现出更高的盈利能力指数，可提供具有既定质量的产品。然而，mRNA 的效价、所涉及的简化和可扩展的合成工艺以及原材料的可用性，使得这些疫苗能够更快地进入市场并具有产品灵活性，在需要短产品开发周期时，这些疫苗更具优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/d3ae75bd2af4/41598_2024_67797_Fig12_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/3c4a9714f705/41598_2024_67797_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/3dcc64fb7e7e/41598_2024_67797_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/d864c28a2667/41598_2024_67797_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/df8d1fd3fa12/41598_2024_67797_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/0594f043a510/41598_2024_67797_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/08e099a0836d/41598_2024_67797_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/f080796eec04/41598_2024_67797_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/31c626379859/41598_2024_67797_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/6366dd18a2d8/41598_2024_67797_Fig9_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/e6af35c2e1be/41598_2024_67797_Fig10_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/c7cea752cac1/41598_2024_67797_Fig11_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/d3ae75bd2af4/41598_2024_67797_Fig12_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/3c4a9714f705/41598_2024_67797_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/3dcc64fb7e7e/41598_2024_67797_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/d864c28a2667/41598_2024_67797_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/df8d1fd3fa12/41598_2024_67797_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/0594f043a510/41598_2024_67797_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/08e099a0836d/41598_2024_67797_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/f080796eec04/41598_2024_67797_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/31c626379859/41598_2024_67797_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/6366dd18a2d8/41598_2024_67797_Fig9_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/e6af35c2e1be/41598_2024_67797_Fig10_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/c7cea752cac1/41598_2024_67797_Fig11_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ae/11408659/d3ae75bd2af4/41598_2024_67797_Fig12_HTML.jpg

相似文献

1
COMPARING vaccine manufacturing technologies recombinant DNA vs in vitro transcribed (IVT) mRNA.比较疫苗制造技术：重组 DNA 与体外转录（IVT）mRNA。
Sci Rep. 2024 Sep 18;14(1):21742. doi: 10.1038/s41598-024-67797-x.
2
mRNA vaccines: the most recent clinical applications of synthetic mRNA.mRNA 疫苗：合成 mRNA 的最新临床应用。
Arch Pharm Res. 2022 Apr;45(4):245-262. doi: 10.1007/s12272-022-01381-7. Epub 2022 Apr 15.
3
Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials.用于疫苗和治疗药物的mRNA制造技术的发展：mRNA平台要求以及支持早期临床试验的可扩展生产工艺的开发。
Transl Res. 2022 Apr;242:38-55. doi: 10.1016/j.trsl.2021.11.009. Epub 2021 Dec 4.
4
Vaccination with Messenger RNA: A Promising Alternative to DNA Vaccination.信使 RNA 疫苗接种：一种有前途的 DNA 疫苗替代方案。
Methods Mol Biol. 2021;2197:13-31. doi: 10.1007/978-1-0716-0872-2_2.
5
The Rapid Development and Early Success of Covid 19 Vaccines Have Raised Hopes for Accelerating the Cancer Treatment Mechanism.新冠疫苗的快速研发和早期成功为加速癌症治疗机制带来了希望。
Arch Razi Inst. 2021 Mar;76(1):1-6. doi: 10.22092/ari.2021.353761.1612. Epub 2021 Mar 1.
6
Producing Plasmid DNA Template for Clinical Grade RNA Vaccine Manufacture.生产用于临床级RNA疫苗制造的质粒DNA模板。
Methods Mol Biol. 2024;2786:303-319. doi: 10.1007/978-1-0716-3770-8_14.
7
mRNA-based therapies: Preclinical and clinical applications.mRNA 疗法：临床前和临床应用。
Int Rev Cell Mol Biol. 2022;372:1-54. doi: 10.1016/bs.ircmb.2022.04.007. Epub 2022 Jun 3.
8
Purification of linearized template plasmid DNA decreases double-stranded RNA formation during IVT reaction.线性化模板质粒DNA的纯化可减少体外转录反应期间双链RNA的形成。
Front Mol Biosci. 2023 Sep 29;10:1248511. doi: 10.3389/fmolb.2023.1248511. eCollection 2023.
9
Fish vaccine antigens produced or delivered by recombinant DNA technologies.通过重组DNA技术生产或递送的鱼类疫苗抗原。
Dev Biol Stand. 1997;90:267-77.
10
Vaccine process technology-A decade of progress.疫苗工艺技术——十年的进步。
Biotechnol Bioeng. 2024 Sep;121(9):2604-2635. doi: 10.1002/bit.28703. Epub 2024 May 6.

引用本文的文献

1
mRNA Vaccine Technology Beyond COVID-19.新冠疫情之后的mRNA疫苗技术
Vaccines (Basel). 2025 May 31;13(6):601. doi: 10.3390/vaccines13060601.
2
Beyond the Pandemic Era: Recent Advances and Efficacy of SARS-CoV-2 Vaccines Against Emerging Variants of Concern.后疫情时代：SARS-CoV-2疫苗针对新出现的关注变异株的最新进展与效果
Vaccines (Basel). 2025 Apr 17;13(4):424. doi: 10.3390/vaccines13040424.
3
Enhancing Chimeric Antigen Receptor T-Cell Generation via Microfluidic Mechanoporation and Lipid Nanoparticles.通过微流控机械穿孔和脂质纳米颗粒增强嵌合抗原受体T细胞的生成

本文引用的文献

1
Pharma 4.0-Artificially Intelligent Digital Twins for Solidified Nanosuspensions.制药4.0——用于固化纳米混悬液的人工智能数字孪生体
Pharmaceutics. 2022 Oct 3;14(10):2113. doi: 10.3390/pharmaceutics14102113.
2
RNA-based therapeutics: an overview and prospectus.基于 RNA 的治疗学：概述与展望。
Cell Death Dis. 2022 Jul 23;13(7):644. doi: 10.1038/s41419-022-05075-2.
3
Quality by Design for enabling RNA platform production processes.通过设计质量使 RNA 平台生产工艺成为可能。
Small. 2025 Apr;21(17):e2410975. doi: 10.1002/smll.202410975. Epub 2025 Mar 19.
Trends Biotechnol. 2022 Oct;40(10):1213-1228. doi: 10.1016/j.tibtech.2022.03.012. Epub 2022 Apr 29.
4
mRNA Therapeutic Modalities Design, Formulation and Manufacturing under Pharma 4.0 Principles.基于制药4.0原则的mRNA治疗方式的设计、制剂与生产
Biomedicines. 2021 Dec 27;10(1):50. doi: 10.3390/biomedicines10010050.
5
A phase 1 trial of lipid-encapsulated mRNA encoding a monoclonal antibody with neutralizing activity against Chikungunya virus.一项针对脂质包裹的编码具有中和抗基孔肯雅病毒活性的单克隆抗体的 mRNA 的 1 期临床试验。
Nat Med. 2021 Dec;27(12):2224-2233. doi: 10.1038/s41591-021-01573-6. Epub 2021 Dec 9.
6
Integrating Elastic Tensor and PC-SAFT Modeling with Systems-Based Pharma 4.0 Simulation, to Predict Process Operations and Product Specifications of Ternary Nanocrystalline Suspensions.将弹性张量和PC-SAFT建模与基于系统的制药4.0模拟相结合，以预测三元纳米晶悬浮液的工艺操作和产品规格。
Pharmaceutics. 2021 Oct 22;13(11):1771. doi: 10.3390/pharmaceutics13111771.
7
Pharma 4.0 Continuous mRNA Drug Products Manufacturing.制药4.0：连续mRNA药品制造
Pharmaceutics. 2021 Aug 31;13(9):1371. doi: 10.3390/pharmaceutics13091371.
8
Biopharmaceutics 4.0, Advanced Pre-Clinical Development of mRNA-Encoded Monoclonal Antibodies to Immunosuppressed Murine Models.生物药剂学4.0，针对免疫抑制小鼠模型的mRNA编码单克隆抗体的高级临床前开发。
Vaccines (Basel). 2021 Aug 11;9(8):890. doi: 10.3390/vaccines9080890.
9
Toward QbD Process Understanding on DNA Vaccine Purification Using Design of Experiment.通过实验设计实现对DNA疫苗纯化的质量源于设计过程理解
Front Bioeng Biotechnol. 2021 May 12;9:657201. doi: 10.3389/fbioe.2021.657201. eCollection 2021.
10
Sildenafil 4.0-Integrated Synthetic Chemistry, Formulation and Analytical Strategies Effecting Immense Therapeutic and Societal Impact in the Fourth Industrial Era.西地那非4.0——综合合成化学、制剂与分析策略，在第四次工业时代产生巨大治疗与社会影响。
Pharmaceuticals (Basel). 2021 Apr 15;14(4):365. doi: 10.3390/ph14040365.