The COVID-19 pandemic has had a lasting impact across many industries — particularly the biopharmaceutical industry, which was mobilized by an mRNA vaccine production effort on a large scale and accelerated time lines. As a leading contract development and manufacturing organization (CDMO), Samsung Biologics was involved in this effort as a manufacturer of Moderna’s COVID-19 vaccine. In a recent article in the European Biopharmaceutical Review, James Park, executive vice president and chief business officer at Samsung Biologics, reflects on how industry adaptations during the pandemic will inform future drug development and manufacturing, highlighting the importance of innovation and adaptability to new technologies as exemplified by mRNA vaccine production.
“Although mRNA technologies presented what could be described as a ‘magic bullet,’ offering the ability for vaccines to be produced quickly and at scale, delivering these products to the global population was certainly no small feat,” said Park. “At the point of peak demand for pharmaceuticals, many drug developers quickly looked to CDMOs to support the development, manufacture, and distribution of mRNA vaccines to patients around the world.”
As Park explains, CDMOs such as Samsung Biologics have now learned from this process and are applying the lessons of mRNA vaccine production to future drug development and manufacturing efforts.
The Benefits of mRNA Vaccine Production
According to Park, mRNA vaccine production was the ideal solution for COVID-19 vaccines for three reasons: safety, efficacy, and ease of production.
First, mRNA vaccines differ from traditional vaccines in that they don’t involve infecting the body with a small amount of a virus to stimulate an immune response. Instead, these vaccines transfer mRNA to the body, which instructs cells to construct spike proteins that combat the virus. The mRNA then quickly dissolves; it doesn’t have any effect on the genes of the patients. This combination of noninfectiousness and nonintegration makes mRNA vaccines a safe option for the general population.
Second, mRNA vaccines can be modified to ensure higher stability and translatability. mRNA encapsulated with lipid nanoparticles allows for rapid uptake and expression by the body’s cells, resulting in efficacious prevention of COVID-19.
Third, mRNA vaccine production can be conducted quickly and is easily scalable with the right approach and technology. While traditional vaccines require growing a virus in mammalian cells or chicken eggs, mRNA vaccines are produced through an in vitro — meaning outside of cells — transcription process, which is a more time-efficient, cost-effective, and scalable process for global production.
Adapting to mRNA Vaccine Production Challenges
Despite these benefits, vaccine developers and manufacturers had to adapt to respond to the challenges of mRNA vaccine production.
For example, the production of lipid nanoparticles posed a challenge for those that worked predominantly with water-based solutions, and because mRNA requires extremely cold temperatures to maintain stabilization, CDMOs had to adjust their cold chain storage capabilities. In addition, CDMOs had to optimize processes to produce mRNA vaccines on accelerated time lines and adapt to supply chain shortages presented by the pandemic.
Samsung Biologics and the Future of Drug Development and Manufacturing
Samsung Biologics was able to meet the challenges of mRNA vaccine production during the pandemic, providing fill/finish services for Moderna’s COVID-19 mRNA vaccine at its facilities in Songdo, South Korea.
And the CDMO has built on this experience to expand its mRNA vaccine production capabilities. In addition to the drug product services it offered for Moderna’s vaccine, Samsung Biologics has implemented drug substance services. It can now provide end-to-end mRNA vaccine production at a single facility. This process includes plasmid DNA (pDNA) linearization, in vitro mRNA transcription, liquid nanoparticle encapsulation, cold chain storage, and fill/finish services. Because the entire process is carried out at a single facility, Samsung Biologics can mitigate transportation and supply chain risk.
Samsung Biologics’ first end-to-end mRNA vaccine production project is the production of COVID-19 vaccines for GreenLight Biosciences, but Park believes that there’s significant potential for future mRNA development and manufacturing projects as mRNA research and development continues to progress.
“Now, mRNA technologies are 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 Park.
He notes that therapies in development include drugs for ovarian cancer, lymphomas, melanomas, and glioblastomas, as well as ischemic heart disease, rare infectious diseases such as Zika virus and Chikungunya virus, and more common viruses such as HIV.
“The ability to support the production of emerging drug modalities including mRNA will be key to overcoming the hurdles associated with overcoming disease globally,” said Park. “As mRNA can be easily edited, it has the potential to offer a ‘plug-and-play’ style platform, delivering the unprecedented versatility needed to respond to unfamiliar biological threats rapidly.”
While the pandemic forced CDMOs to adapt, Samsung Biologics has taken on the challenge and continued to grow throughout, recording record profits in 2021 and record year-over-year growth in the first quarter of 2022. In addition to its new mRNA vaccine production facility, Samsung Biologics is in the process of increasing capacity with the construction of its fourth plant in Songdo, and it’s planning to construct a second Bio Campus that will be 30% larger than its current Bio Campus.
The adaptation of facilities and processes in response to the pandemic has left the CDMO more agile and prepared to adapt to innovation or unexpected biopharmaceutical needs in the future.
“As well as supporting new mRNA technologies, CDMOs that have adapted their capabilities and facilities during the pandemic are now well-placed to support new therapies on the horizon,” said Park. “CDMOs will need to learn from the past, identifying the processes and technologies that allowed them to overcome the challenges of the pandemic, and ensuring those lessons are instilled in the future.”