Department of Bioengineering, iBB-Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1049-001 Lisboa, Portugal.
Department of Bioengineering, iBB-Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1049-001 Lisboa, Portugal.
Vaccine. 2021 Apr 15;39(16):2190-2200. doi: 10.1016/j.vaccine.2021.03.038. Epub 2021 Mar 24.
Vaccines are one of the most important tools in public health and play an important role in infectious diseases control. Owing to its precision, safe profile and flexible manufacturing, mRNA vaccines are reaching the stoplight as a new alternative to conventional vaccines. In fact, mRNA vaccines were the technology of choice for many companies to combat the Covid-19 pandemic, and it was the first technology to be approved in both United States and in Europe Union as a prophylactic treatment. Additionally, mRNA vaccines are being studied in the clinic to treat a number of diseases including cancer, HIV, influenza and even genetic disorders. The increased demand for mRNA vaccines requires a technology platform and cost-effective manufacturing process with a well-defined product characterisation. Large scale production of mRNA vaccines consists in a 1 or 2-step in vitro reaction followed by a purification platform with multiple steps that can include Dnase digestion, precipitation, chromatography or tangential flow filtration. In this review we describe the current state-of-art of mRNA vaccines, focusing on the challenges and bottlenecks of manufacturing that need to be addressed to turn this new vaccination technology into an effective, fast and cost-effective response to emerging health crises.
疫苗是公共卫生领域最重要的工具之一，在传染病控制中发挥着重要作用。由于其精确性、安全性和灵活的制造工艺，mRNA 疫苗作为传统疫苗的替代方案备受关注。事实上，mRNA 疫苗是许多公司应对新冠疫情的首选技术，也是美国和欧盟首次批准用于预防治疗的技术。此外，mRNA 疫苗正在临床研究中用于治疗多种疾病，包括癌症、艾滋病、流感，甚至遗传性疾病。对 mRNA 疫苗的需求增加需要一个技术平台和具有成本效益的制造工艺，以及明确的产品特征。mRNA 疫苗的大规模生产包括 1 或 2 步体外反应，然后是一个多步的纯化平台，其中可能包括 DNA 酶消化、沉淀、色谱或切向流过滤。在这篇综述中，我们描述了 mRNA 疫苗的现状，重点介绍了制造过程中的挑战和瓶颈，需要解决这些问题才能将这种新型疫苗技术转化为应对新出现的健康危机的有效、快速和具有成本效益的反应。
