Artificial intelligence seems to be on everyone’s mind in recent months, with forecasts of revolutionary potential in industry, art, and science. It remains to be seen how accurate these forecasts are, but there are already some established use cases of machine learning that are changing our world, particularly in medicine. Perhaps the most significant recent example is the use of AI and other high-tech to accelerate research and mRNA vaccine production to produce COVID-19 vaccines.
Contract development manufacturing organization (CDMO) Samsung Biologics is focusing on building the manufacturing infrastructure to support this innovation in biopharmaceutical technology, investing in an end-to-end mRNA vaccine production suite that provides both drug substance and drug product service. As researchers continue to pursue new applications of mRNA with the help of the latest technology, Samsung Biologics is hoping to accelerate development and manufacturing time lines with cutting-edge mRNA facilities and services.
“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 AI-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.”
The Role of AI in mRNA Research
Advancements in AI and mRNA technology have led to the reduction of new drug development time lines for vaccines from several years to several months, said Eonyoung.
The mRNA vaccine technology used for COVID vaccines is a new and innovative approach that uses synthetic RNA molecules to instruct cells to produce viral proteins that stimulate an immune response against the virus.
There are several ways in which AI has been useful in designing and testing these molecules, all of which leverage machine learning’s ability to analyze large sets of data and make predictions, which can then be examined and tested by researchers, drastically reducing development time lines.
First, AI techniques can analyze viral protein sequences and predict which parts of the virus are most likely to trigger an immune response. This helps identify potential targets for vaccine development.
AI can also help optimize the mRNA sequences used in vaccines, analyzing the structure of RNA molecules and predicting which modifications will improve their effectiveness in targeting a virus or tumor. In terms of vaccine delivery systems, AI can help identify the best lipid nanoparticles and other components that protect the mRNA molecules from degradation and facilitate their uptake into cells.
Once a vaccine has been developed, AI can help design and analyze clinical trials by identifying patient populations that are most likely to benefit from the vaccine, predicting the safety and efficacy of the vaccine, and optimizing the dosing regimen.
How Samsung Biologics Supports mRNA Vaccine Production
As a CDMO in this rapidly evolving mRNA vaccine production space, Samsung Biologics is focusing on providing cutting-edge technology and services for partners working in mRNA technology.
After providing fill/finish services for Moderna’s COVID vaccine in 2021, Samsung Biologics expanded its mRNA vaccine production capabilities by adding drug substance services. The CDMO can now produce the plasmid DNA (pDNA), mRNA, LNPs, and other components required to manufacture a vaccine.
It also purifies the mRNA with ultrafiltration and encapsulates it in LNPs using precise pump mixing technology. The final drug product is produced through aseptically filling vials and providing packaging and labeling. Cold storage is necessary throughout the process, and Samsung Biologics utilizes upright and walk-in storage systems with temperatures as low as minus 70 degrees Celsius as needed.
All of these services are carried out in a single facility at Samsung Biologics headquarters in Songdo, South Korea. The goal is to minimize risk of contamination in transport and to accelerate time lines with a one-stop shop.
“Frequent handling of mRNA in multiple locations increases contamination and degradation risks, but when the entire work stream from pDNA to vial is coordinated by one partner from a single location, transitions across development and production tasks run smoothly, maximizing efficiency and eliminating these potential risks,” Samsung Biologics’ Pierre Catignol, executive vice president and head of manufacturing, and Huisub Lim, lead scientist of mRNA manufacturing, wrote in a recent white paper.
Samsung Biologics’ first demonstration of these end-to-end capabilities was the completion of a commercial-scale mRNA vaccine production run for GreenLight Biosciences COVID vaccine candidate in July 2022. The run was completed just seven months after the initial technology transfer and produced 650 grams of mRNA at a titer of 12 grams per liter.
While all mRNA vaccines produced up to this point have been for COVID applications, the biopharmaceutical industry is optimistic about applications for mRNA in a wide variety of other areas, including targeted cancer treatments, treatments for autoimmune diseases, and vaccines for infectious diseases such as HIV, influenza, and Zika virus.
As researchers continue to utilize AI and other innovative approaches to advance toward these new applications, Samsung Biologics will look to become a leading manufacturing partner in the burgeoning mRNA market.
