The mRNA vaccine technology has shown promising results in the fight against different pathogens. However, mRNA must undergo extensive manufacturing to become a safe and efficient vaccine or therapeutic.
mRNA is an unstable molecule highly sensitive to shear stress or enzymatic degradation. It is, therefore, essential to select the correct delivery tool to ensure that mRNA remains intact until it is taken up by the cells.
Cost
One of the most significant benefits of mRNA vaccines is that they are significantly cheaper to make than traditional vaccines. This is because mRNA vaccines don’t require animal cell biology but instead rely on a chemical biochemical process using synthetic enzymes. The host cells then translate the mRNA molecules into immunogenic proteins, creating the desired vaccine. In contrast, traditional vaccines require the use of a live virus.
MRNA vaccines also have a much shorter production timeline. While viral vaccines need several months to produce a single batch, mRNA vaccines can be made within weeks after the sequence encoding the target antigen is available. In addition, mRNA vaccines are more scalable than other kinds of vaccines.
Despite these advantages, mRNA vaccines still face significant cost challenges. For example, the mRNA vaccine manufacturing process is susceptible to shear stress and enzymatic degradation by ribonucleases. Therefore, any raw materials, solutions, or equipment that come into contact with the mRNA must be RNase-free. This is a substantial cost driver, and alternative processing approaches should be explored to reduce costs.
In addition, mRNA vaccines are also highly sensitive to temperature fluctuations. They require ultracold-chain logistics to deliver them to distribution sites. This could raise supply chain costs, especially in low-income countries. As a result, it’s essential to develop manufacturing centers in multiple regions of the world to make these vaccines affordable for everyone.
Safety
mRNA vaccines are a promising approach to treat many diseases. They deliver mRNA-encoding antigens into cells, translating them into functional proteins that the immune system recognizes as foreign to the body. This enables the immune system to mount an attack against the pathogen and prevents re-infection. In addition, mRNA vaccines are highly efficient and can be delivered via multiple routes. Moreover, they are stable and have long half-lives. Compared to traditional vaccines, mRNA vaccines can be developed and manufactured in a short time frame.
Despite their many benefits, mRNA vaccines are fragile and require extremely low temperatures to remain active. They are also susceptible to degradation by ribonucleases (RNases). To ensure the quality of the vaccine, all the materials that come into contact with mRNA must be free of these enzymes. This is especially crucial during manufacturing, as any RNase can degrade mRNA within seconds. To overcome this problem, mRNA can be packaged in polymers, which protect the molecules from enzymatic degradation.
mRNA vaccines can be produced relatively quickly, making them viable for pandemic responses. In addition, they can be produced locally in developing countries using Good Manufacturing Practices (GMP) facilities. The technology is also scalable and can be used for different target diseases.
Efficacy
As with all vaccines, the effectiveness of an mRNA-based vaccine depends on its delivery into human cells. This is an area of intense research as a range of novel ionizable lipid formulations are being developed. These can help improve mRNA stability during storage and transportation, making it easier to deliver into cells.
An mRNA-based vaccine is a blueprint that instructs the cell to construct a specific protein. When injected into a patient, this protein triggers an immune response that can effectively protect against the target pathogen.
In addition, mRNA-based vaccines are much faster to manufacture than conventional vaccines. This is because they don’t use viruses, meaning fewer complicated steps are involved. Additionally, mRNA is less susceptible to contamination than other vaccine manufacturing methods, which reduces the risk of potential side effects.
While there are still challenges to overcome in developing mRNA-based vaccines, they could be an effective strategy for controlling future pandemics. The key challenge is delivering the vaccine to the appropriate cells quickly enough to help manage a global outbreak. This requires scalable production and flexible processes. It’s also essential to ensure the vaccine can be rapidly revised in response to new COVID-19 variants. mRNA-based vaccines are an excellent option, as they can be produced quickly using a cell-free process and modified to match any protein sequence.
Sustainability
mRNA vaccines are designed to deliver a transcript of an immunogenic sequence into the host cell, which is expressed and generates translated proteins that are secreted or located within the cell. The field is pursuing two approaches: non-replicating and self-amplifying mRNA constructs. Both categories require specific ionizable lipid formulations and delivery systems to elicit adequate immune responses.
Unlike viral vaccines, which are produced in cells and require vast quantities of animal cells (lots and lots of eggs), mRNA vaccines can be manufactured at an industrial scale using a cell-free process. Moreover, their production costs are much lower than conventional vaccines. In addition, mRNA vaccines can be rapidly produced once the template DNA is available.
Conclusion
In conclusion, the speed of mRNA vaccine manufacturing is limited by the need to ensure that the vaccines are safe and stable. This requires careful characterization of the target sequence and of the final product. It also requires specialized storage and shipping conditions. The mRNA vaccines need to be kept at ultra-cold temperatures.
This complicates the supply chain and requires investment in cold-chain logistics, which is expensive for low-income countries. Ultimately, global access to mRNA vaccines must be ensured through a legal framework that encourages and enforces companies to share their technologies.
