mRNA vaccines pharmaceutical manufacturing innovation consulting

How are mRNA vaccines transforming the pharmaceutical manufacturing?

In 2018, mRNA vaccines were still referred to as a ‘promising alternative’ to conventional vaccine approaches to vaccine production. 3 years later, facing the Covid-19 pandemic, the U.S. buys more than 500 million doses of mRNA vaccine Moderna. Big pharmaceutical companies, such as Sanofi or Merck, have acquired mRNA research companies. Clearly, the pandemic boosted the development of mRNA vaccines. How could this new approach transform the pharmaceutical manufacturing of vaccines? Alcimed discussed the large potential of mRNA therapeutics for the field of oncology and respiratory disease in 2017. In this article, Alcimed will go a step further and explore how these mRNA vaccines might transform the pharmaceutical manufacturing in the future.

What are the advantages of mRNA vaccines?

mRNA vaccines contain information from mRNA, with a code of a specific virus antigen. After a vaccination with a mRNA vaccine, the information induces the manufacturing of this specific antigen. Body cells then present this antigen on their surface and trigger the desired immune response. As mRNA vaccines do not involve biological processes (e.g. production of a inactivated virus), they can more easily be synthesized in the lab: allowing for faster, cheaper and less risky development of new vaccines.

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How could these advantages transform pharmaceutical manufacturing?

Simplified manufacturing processes with mRNA vaccines

The mRNA vaccine development does require simpler and more straightforward processes than traditional vaccine development. Consequently, a simplified vaccine manufacturing process is possible. Allowing for a faster and more cost-efficient response to outbreaks of new infectious diseases.

Safer manufacturing with mRNA vaccines

Within the traditional vaccine manufacturing processes, safety was a concern. For the development of a vaccine, a large quantity of the pathogen that was causing the disease was necessary. This posed a major risk to the operators in the process. Furthermore, patient safety had to be considered all the time, as it needs to be sure that the virus in the vaccine has been inactivated or attenuated (without being able to revert to its pathogenic form). As mRNA vaccines do not contain the pathogen itself, manufacturing is expected to be safer.

Manufacturing for combinations of diseases

Traditional manufacturing often meant ‘one drug for one bug’. Meaning that the manufacturing process for a vaccine had to be tailored to one disease as the manufacturing process included the production of the pathogen itself.

For each new disease, new processes were necessary to learn about the pathogen and how to produce it on large scale. On the contrary, mRNA vaccine development processes allow for simpler manufacturing processes that can potentially be used for multiple diseases.  Plans are now made for combination vaccines; vaccines with multiple RNAs to target e.g. both the flu and COVID-19.

Bottlenecks of mRNA vaccine production

Although there are many advantages of mRNA vaccine production, there are quite some issues that still must be tackled. Many of them lay within the field of supply chain. Examples include:

  • Lack of raw materials: Currently, the production of raw materials is still a bottleneck. The lipids needed for the vaccines (LNP) were previously mainly produced for research studies, the current demand for these materials is higher than the supply.
  • Storing cold enough: the vaccines need to be stored in specific freezers, that keep the vaccines at a cold enough temperature. Once stored in a normal fridge, the vaccines must be used within 5 days.
  • Scaling: Although making the mRNA for the vaccines itself is relatively uncomplicated and fast, there are only few contract manufacturing organizations with expertise and scale to contribute meaningfully to make the vaccines. Big players are needed to produce enough vaccines for the rising demand.

To date, mRNA vaccines are only on the market for infectious diseases. However, there is an enormous potential for non-infectious diseases. Research now focuses on new treatments for oncology and even genetic disorders. mRNA vaccine production is expected to grow rapidly. KOLs expect a quicker, safer, and cheaper process of manufacturing and the possibility to combine several vaccines in one shot. However, major investments must be done to monitor long-term effects, study new applications and overcome practical barriers and bottlenecks. Alcimed will keep you up to date on new developments in the field!

About the author,

Hannah, Consultant in the Alcimed’s Healthcare team in Germany

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