What Will mRNA Vaccine Production Look Like Post-COVID? Scientists at CDMO Samsung Biologics Discuss
The COVID-19 pandemic has introduced the world to the potential of mRNA vaccines. Prior to the pandemic, research into mRNA vaccines had been progressing for decades, but the global health crisis accelerated research and development as the biopharmaceutical community recognized that mRNA's editability and manufacturing scalability made it an ideal fit for combating the virus. Now, successful mRNA vaccine production has been achieved on an international scale and the industry is looking to build on this success to develop the next generation of innovative biologic medicines.
Scientists and executives at Samsung Biologics, one of the world's largest contract development and manufacturing organizations (CDMOs), hope that the company can play a central role in mRNA vaccine production's evolution in the wake of the pandemic. While COVID-19 continues to be a primary focus of mRNA technology as the pandemic persists, the success of mRNA vaccines for COVID-19 applications has opened the door for research and development into mRNA vaccine production for other applications post-COVID.
MRNA technologies are now frequently being used in abundance as drugs in clinical trials, targeting well-known diseases, including cancers, further highlighting the benefits of CDMOs adapting to their production, said Samsung Biologics chief business officer and Executive Vice President James Park in a recent article for the European Biopharmaceutical Review. Therapies in development include drugs for cancers (ovarian, lymphomas, melanomas, glioblastomas), ischemic heart disease, rare diseases (caused by Zika virus, Chikungunya virus), and other more common diseases (e.g., HIV).
Adapting to mRNA Vaccine Production
Alongside these developments in mRNA technology, manufacturers are learning lessons from the pandemic and adapting their mRNA vaccine production strategies and capabilities to accommodate demand for mRNA manufacturing and development at large scales.
For Samsung Biologics, this has meant developing an end-to-end mRNA vaccine production suite, which can handle drug substance and drug product services at a single facility.
Samsung Biologics provided aseptic fill/finish services for Moderna's COVID-19 mRNA vaccine in 2021, transferring Moderna's mRNA drug substance to vials while ensuring vaccines were uncontaminated and stored at the appropriate temperature. It also handled labeling and packaging of the vaccines at its facilities in Songdo, South Korea.
The CDMO has now expanded these capabilities. While it can still provide aseptic fill/finish services and labeling and packaging, the new suite enables it to produce the active mRNA drug substance at the same facility, reducing the risk of degradation that can occur from transporting mRNA and improving manufacturing timelines.
Adapting its facilities to produce mRNA has involved developing capabilities to linearize circular plasmid DNA (pDNA), transcribe it to a purified mRNA molecule, and produce lipid nanoparticles (LNPs) used to coat mRNA molecules and ensure stability. It also utilizes advanced cold-chain storage capabilities and performs stability testing via a dedicated modeling, simulation, analysis and test laboratory.
Samsung Biologics' mRNA vaccine production suite is designed for a variety of scales and needs, explained head of manufacturing and Executive Vice President Pierre Catignol and lead scientist of mRNA manufacturing Huisub Lim in a recent Q&A.
More than 150 clinical trials currently are in development at various stages of the life cycle. Samsung Biologics combines our expertise and experience with a broad equipment library to cater to clients' differing volume needs. Most Samsung Biologics clients are developers starting at the discovery and preclinical stage. They require existing knowledge to prove their system in terms of [data science] life cycle. Accordingly, some clients require end-to-end service, while others want a contract limited to pDNA development or the LNP process.
The Potential of mRNA
While COVID-19 applications have been the focus of mRNA vaccine production up to this point, the same benefits that make mRNA an effective option to combat the pandemic give it the potential to succeed across other applications. These benefits include safety, precise targeting and editability, and cost-efficient rapid scaling of production.
Unlike traditional vaccines, which infect the body with a small portion of a virus to stimulate an immune response, mRNA vaccines are noninfectious; they work by instructing the body's cells to produce disease-fighting proteins. Because the efficacy of mRNA vaccines relies on the coding of these instructions rather than on growing a virus in living cells, they can be easily edited to adapt to mutating viruses or to precisely target diseases such as cancers. And the production of mRNA vaccines can be rapidly scaled, thanks to the accelerated timeline of this in vitro (outside of a living cell or organism) approach to vaccine development.
These benefits mean that mRNA can be an effective tool to combat a variety of fast-evolving viruses, as well as a tool to provide targeted vaccines for individualized cancer treatments. In fact, a recent Nature report estimated that the total market for mRNA-based personalized cancer vaccines will reach $7 billion to $10 billion by 2035.
In addition to the direct potential of mRNA, the downstream effects of developing mRNA vaccine production capabilities could reach other areas of biologic medicine, as Lim explained in a recent biopharmaceutical industry roundtable.
Despite the difficulties associated with supporting the manufacturing of this relatively new and unfamiliar technology, some CDMOs rose to the challenge and embraced the learning curve. They balanced the needs of these new projects with those ongoing by expanding their facilities and capabilities. As a result, these CDMOs are now better placed than ever to support emerging technologies, including cell and gene therapies (C>s). Their experience pivoting to accommodate new processes and optimize them will go hand in hand with their increased capacity to smoothly scale C> manufacturing and development to commercial sizes in future.
The broader biologics market continues to grow, with an estimated compound annual growth rate of 8.4% by 2028. mRNA vaccine production looks to play a significant role in this growth, and not just in the area of COVID-19 applications. And the growth of the biologics market comes as pharmaceutical companies are increasingly turning to CDMOs and a distributed manufacturing model. According to the experts at Samsung Biologics, expanding mRNA vaccine production capabilities is the appropriate response to these trends.