Research into the therapeutic use of messenger ribonucleic acid (mRNA) had been ongoing for decades prior to the COVID-19 pandemic. Now, the global community is looking at mRNA technology as the potential answer for fast vaccine delivery.
What makes mRNA vaccines different from traditional formations? Instead of injecting someone with part of a pathogen, mRNA-based vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease. When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response.
Advantages of mRNA vaccines
The mechanism and manufacturing of mRNA vaccines offer many advantages to developers, including quick development, high potency, a favourable safety profile and the potential for cost-effective production. This modality could help efficiently control rapidly spreading infectious diseases.
mRNA vaccines can be made more quickly than traditional vaccine platforms because they are produced using an in vitro synthetic process that does not require the time-consuming growth or removal of cells and proteins. Platforms designed to create RNA can also be easily adjusted to target a range of indications or mutated versions of the same virus. This adaptability is what allowed Pfizer and BioNTech to redirect their existing mRNA platform from cancer to COVID in a matter of weeks.
Expanding mRNA vaccine use cases
Now that evidence suggests mRNA to be a safe and effective technology, researchers are hoping to use it to accelerate vaccine development for other indications. Unsurprisingly, companies that had success with mRNA during COVID-19 are now looking to expand to new applications. According to GlobalData, 85% of planned mRNA vaccine trials in 2023 are sponsored by industry, up from 34% of mRNA trials initiated in 2021. Moderna and Pfizer hold the two largest mRNA vaccine trials in 2023, for seasonal influenza.1
With focused attention and quick-moving research, exciting developments are expected in the field of mRNA.
Arcturus Therapeutics is another company to watch, as they are currently working on an influenza vaccine based on a proprietary self-amplifying mRNA platform. In August 2022, the Biomedical Advanced Research and Development Authority awarded Arcturus $63.2 million in funding to support this work.2
Challenges in mRNA development
With focused attention and quick-moving research, exciting developments are expected in the field of mRNA. However, there are still challenges to overcome to fully realise mRNA’s potential.
To start, the stability of mRNA formulations can pose a challenge, as they are prone to degradation by ubiquitous enzymes and require strict temperature control and cold chain logistics. From a safety perspective, there is also a potential for an unwanted immune response and allergic reaction following patient administration.
When it comes to mRNA processing, dedicated consumables and equipment options suited to its characteristics are currently limited.3 An imbalance between supply and demand of plasmid DNA — a key raw material in mRNA production — has additionally become a bottleneck.
Tools to enable a rapid health response
Cytiva offers solutions across the mRNA manufacturing workflow, from plasmid linearisation to aseptic filling. For example, KUBio™ modular ‘box’ environments by Cytiva are designed to support rapid response manufacturing of mRNA in a Biosafety Level 1 (BSL-1) environment.
Installed inside that purpose-built environment, the FlexFactory™ platform can serve as an end-to-end manufacturing solution for mRNA drugs. The Figurate™ automation platform provides a central data repository, enabling process analytics, reporting and regulatory compliance.
Achieving CEPI’s ‘100 Days Mission’ will require flexible, configurable and scalable manufacturing solutions. This fast turnaround time will also require a tool provider that is reliable and responsive, delivering high-quality systems with efficiency. When the next epidemic strikes, Cytiva will be ready to support the industry in rising to the challenge of a truly rapid response.
[1] GlobalData. Clinical Trials Arena. mRNA vaccines: four major clinical trial readouts to watch in 2023.
[2] Yahoo Finance. Arcturus Announces $63.2 Million Award from the U.S. Government to Support Development of Self-amplifying mRNA Vaccine for Rapid Pandemic Influenza Response.
[3] Cytiva. mRNA vaccines: current trends and perspectives.