Elsevier

Vaccine

Volume 39, Issue 16, 15 April 2021, Pages 2190-2200
Vaccine

Review
mRNA vaccines manufacturing: Challenges and bottlenecks

https://doi.org/10.1016/j.vaccine.2021.03.038Get rights and content

Highlights

  • mRNA is a safe and precise vaccine technology.

  • Over 140 clinical trials can be found using mRNA vaccines.

  • Scalability and cost-effectiveness in mRNA manufacturing is still a bottleneck.

  • Continuous manufacturing can potentially be used in the mRNA technology manufacturing.

Abstract

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.

Keywords

Vaccination
mRNA vaccines
mRNA manufacturing
mRNA applications

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