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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.

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/11408659/3c4a9714f705/41598_2024_67797_Fig1_HTML.jpg

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