4.5 Review

mRNA vaccines manufacturing: Challenges and bottlenecks

Journal

VACCINE
Volume 39, Issue 16, Pages 2190-2200

Publisher

ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2021.03.038

Keywords

Vaccination; mRNA vaccines; mRNA manufacturing; mRNA applications

Funding

  1. Fundacao para a Ciencia e a Tecnologia (FCT) [SFRH/BD/148437/2019]
  2. iBB-Institute for Bioengineering and Biosciences [UIDB/04565/2020]
  3. Future Biomanufacturing Research Hub [EP/S01778X/1]
  4. Engineering and Physical Sciences Research Council (EPSRC)
  5. Biotechnology and Biological Sciences Research Council (BBSRC), UK Research and Innovation
  6. Fundação para a Ciência e a Tecnologia [SFRH/BD/148437/2019] Funding Source: FCT

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mRNA vaccines are emerging as a new alternative to conventional vaccines, with their precision, safety profile, and flexible manufacturing. They have been used to combat the Covid-19 pandemic and are being studied for other diseases as well. However, challenges in manufacturing, technology platform, and cost-effective production need to be addressed to fully utilize this new vaccination technology.
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. (C) 2021 Elsevier Ltd. All rights reserved.

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