During the COVID-19 pandemic, mRNA vaccines were developed and approved for emergency use in less than a year, an unprecedented time line for vaccine development. This was made possible by innovations in both research and manufacturing methods. Samsung Biologics, a contract development and manufacturing organization (CDMO) that helped Moderna manufacture its COVID vaccines, is applying the lessons learned from this accelerated process to optimize vaccine development going forward.
“Pharmaceutical companies found that vaccine development time lines can be reduced by several years and accelerated the development of new modalities like mRNA with advanced technologies including [artificial intelligence-] based approaches,” said Eonyoung Park, lead scientist on the mRNA-based research team at Samsung Biologics, in a recent article.
“These fast phases of the development of drugs and the need for preparation against future pandemic situations provide a positive impact on the investment of pharmaceutical companies.”
How MRNA Vaccines Increase Development Speed
MRNA vaccine production differs from traditional vaccine production in terms of both the processes and materials required. Crucially, mRNA vaccines are produced using an in vitro (cell-free) approach, meaning they do not require researchers and manufacturers to grow viruses in live cells.
This is advantageous both because of the speed at which mRNA vaccines can be produced, and the ease with which they can be edited as new strains of a virus emerge or scientists identify adjustments that increase efficacy.
“The technology allows for the development of drugs and vaccines with very specific molecular designs and functionalities targeting many different types of disease mechanisms,” Samsung Biologics head of development sales Esther Yoo wrote in a recent white paper. “The nature of mRNA machinery means that these medicines can target intracellular proteins, which have largely been considered to be untreatable using more traditional drugs.”
She went on to explain that mRNA technology can also be used to instruct the body to produce missing proteins, or to adjust the structure of altered proteins, issues that cause problematic immune responses and life-threatening genetic conditions such as Huntington’s disease. And because mRNA targets the underlying genetics of a disease, mRNA vaccine production and research can help identify the root causes of these conditions in a way that a more reactive, traditional approach to vaccine development does not.
The key for mRNA vaccine production is that the qualities that make mRNA an attractive option for a variety of applications come with the added benefit of the potential for more efficient and agile production.
Traditional vaccines are made by growing large quantities of virus or bacteria in the lab, which can take a long time. In contrast, mRNA vaccines are produced using a synthetic process that does not require the cultivation of large amounts of virus or bacteria. Instead, the mRNA is synthesized in the lab using readily available materials and cutting-edge digital technology, including artificial intelligence that identifies and tests potential effective sequences. This allows for a more streamlined and efficient production process in which information can be easily shared and production can be quickly scaled as needed.
While traditional vaccines often require significant modifications to the production process when new strains of a virus emerge, mRNA vaccines can be adapted relatively quickly to target new variants of a virus. This is because the genetic code of the mRNA can be easily altered to reflect changes in the virus’s genetic makeup.
And mRNA vaccines have safety benefits. They have been shown to be safe and effective, with the mRNA leaving the body after instructing the cells to produce the desired effect. They do not use live viruses or bacteria, which can reduce the risk of adverse effects. These safety benefits can help expedite the regulatory approval process for mRNA vaccines.
Samsung Biologics’ Expanded mRNA Vaccine Production Strategy
With these benefits in mind, Samsung Biologics has focused on expanding its mRNA vaccine production capabilities in recent years. Initially, the CDMO was able to provide drug product services, including aseptic fill/finishing, packaging, and labeling. After providing these services to help manufacture Moderna’s COVID vaccine in 2021, Samsung Biologics decided to add drug substance capabilities, and it now offers end-to-end mRNA vaccine production services.
The CDMO can produce the mRNA molecules, lipid nanoparticles, enzymes, and other materials required in house. It sequences mRNA using linearized plasmid DNA (pDNA), purifies the active mRNA drug substance and coats it in LNPs to ensure stability, then transfers it to vials that will ultimately reach patients.
The benefits of this approach are that it reduces the risk of contamination and degradation from transport, and time lines are expedited because all services are carried out in the same facility, avoiding potential supply chain delays and shortages that stall manufacturing.
Demand for mRNA vaccines for non-COVID applications is expected to increase in the upcoming years, with promising trials in the works for treatments ranging from targeted cancer vaccines and vaccines for autoimmune conditions to immunizations for infectious diseases such as influenza, HIV, and Zika virus.
Yoo noted that as of the summer of 2021, there were over 1,800 clinical studies involving mRNA listed in the U.S. National Library of Medicine database, with roughly a quarter of those studies in Phase II.
“The development and approval of mRNA vaccines against the SARS-CoV-2 virus was truly a breakthrough in mRNA therapeutics, which had been explored for decades,” said Yoo. “Many mRNA-based vaccines and therapeutics are expected to address unmet medical needs in the near future beyond fighting SARS-CoV-2 virus and its variants.”