The COVID-19 pandemic has highlighted the transformative potential of mRNA vaccines, revolutionizing the field of vaccinology. As we look beyond the pandemic, the future of mRNA vaccine production and research holds immense promise. At Samsung Biologics, a contract development and manufacturing organization (CDMO) that helped manufacture vaccines during the pandemic, scientists and industry experts are focusing on manufacturing approaches, development techniques, and potential applications that lie ahead. Some of the innovative areas where they’re seeing advancements are in cold chain storage, lipid nanoparticle encapsulation, digital technology and artificial intelligence sequencing, and the expansion of mRNA vaccines into non-COVID disease areas.

“MRNA-based vaccines and therapeutics are receiving considerable attention,” explained Samsung Biologics’ Esther Yoo in a recent white paper. “The technology allows for the development of drugs and vaccines with very specific molecular designs and functionalities targeting many different types of disease mechanisms.

“Moreover, they can be used to treat diseases caused by pathogens or that involve immune-related responses and disorders caused by missing or altered proteins by providing instructions to the patients’ cells to build the specific protein required,” continued Yoo. “Since mRNA is produced using genetic sequence data, it is well suited for personalized medicines.”

Advancements in mRNA Vaccine Production Strategy

One significant challenge in vaccine distribution is maintaining cold enough temperatures throughout the supply chain to ensure the vaccine remains stable. MRNA vaccines require ultra-cold chain storage, and preserving the stability of fragile mRNA molecules requires precision and maintained temperatures that can range from minus 20 to minus 70 degrees Celsius.

For Samsung Biologics, the key has been to establish cold chain technology that can maintain these temperatures, then utilize an end-to-end mRNA vaccine production strategy at a single facility.

“Having mRNA drug substance manufactured at one site, then transferred to another for encapsulation, and a third for fill/finish introduces opportunities for product loss given the fragile nature of mRNA,” explained Samsung Biologics’ Eunseo Lee, Hanel Hwang, and Jungkeun Oh in another recent white paper. “Every time the material experiences high-temperature excursions, it is possible that quality, efficacy, and safety can be negatively impacted.”

Another crucial advancement for mRNA vaccine production has been the improvement of lipid nanoparticle encapsulation of mRNA molecules. This process uses microscopic fat molecules to wrap the mRNA and ensure stability throughout the production process and the delivery of mRNA molecules into the patient’s system.

Ongoing research in the mRNA field is focused on optimizing the encapsulation process to improve vaccine stability, increase cellular uptake, and enhance immune responses. Advancements in lipid nanoparticle formulations are expected to contribute to the development of more efficient and potent mRNA vaccines in the future.

In addition, the use of AI and digital technology, such as machine learning and computational modeling, should continue to accelerate mRNA vaccine development. These tools aid in the identification of optimal mRNA vaccine candidates, prediction of immunogenicity, and analysis of large-scale clinical trial data. By streamlining the design and testing phases, digital technology expedites the development time line and optimizes vaccine efficacy.

Non-COVID Applications for mRNA Vaccines

Yoo explained that there are over 1,800 clinical studies involving mRNA listed in the U.S. National Library of Medicine database, with approximately 25% in Phase II. Candidates target solid-state tumors and diseases such as colorectal cancer, Lyme disease, and autoimmune diseases, among many others.

“Many of these vaccines target infectious diseases that have to date eluded effective vaccine solutions, including malaria, influenza, and HIV/ AIDS. There are also significant efforts underway to develop a universal flu vaccine,” said Yoo. “Many cancer vaccines based on mRNA are also progressing through clinical phases, and there is a growing interest in the potential of mRNA-based cancer immunotherapies.”

MRNA vaccines hold great potential in combating other infectious diseases. Traditional flu vaccines require regular, time-consuming reformulation due to viral strain variations, whereas mRNA vaccines can be rapidly adapted to target new strains. Additionally, mRNA vaccines can elicit broader immune responses, potentially providing cross-protection against related viruses.

The personalized nature of mRNA vaccines makes them ideal candidates for developing targeted cancer vaccines. By incorporating tumor-specific antigens, mRNA vaccines can instruct the immune system to recognize and eliminate cancer cells selectively. This approach harnesses the body’s immune response to combat cancer while minimizing side effects associated with traditional therapies.

MRNA vaccines may also offer a revolutionary approach to addressing genetic conditions like Huntington’s disease. These vaccines can potentially correct or mitigate the underlying genetic defects, opening new avenues for treating genetic disorders that were previously challenging to target directly.

The Future of Vaccines?

The future of mRNA vaccine production and research following COVID-19 holds immense promise. Advancements in manufacturing approaches, development techniques, and the exploration of potential applications beyond COVID-19 showcase the versatility and power of mRNA vaccines.

The continued integration of cutting-edge technologies, such as AI and digital platforms, should also accelerate the discovery, design, and deployment of mRNA vaccines, revolutionizing disease prevention and treatment in the years to come. The experts at Samsung Biologics are optimistic that, with each stride forward, we move closer to a world where mRNA vaccine production plays a pivotal role in eradicating infectious diseases, combating cancer, and offering hope to individuals affected by genetic conditions.

By Manali