MRNA vaccine production has been a topic of increasing investment and interest in the wake of the successful application of mRNA vaccines during the COVID-19 pandemic. After years of research into this promising technology, 2020 saw a breakthrough as the biopharmaceutical research community united to push through the first mRNA vaccines approved for human use.
Researchers had long touted the potential benefits of mRNA vaccines. Which are both easier. To edit and can produce. More quickly than traditional vaccines. The demonstrated use case of effective COVID-19 vaccines has spurred interest in other applications, and Samsung Biologics, one of the world’s largest contract development and manufacturing organizations, is partnering with companies pursuing this innovative technology.
In 2022, the CDMO announced the completion of an end-to-end mRNA vaccine production suite at its Songdo, South Korea, headquarters. It then announced the completion of the first commercial-scale production run at the facility, producing mRNA vaccines for GreenLight Biosciences. The run completed seven months. After the initial technology transfer. Demonstrating the efficiency of mRNA vaccine production.
“This demonstrates a major achievement in our continuing goal to offer one-stop, end-to-end mRNA production from drug substance to aseptic fill/finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said John Rim, CEO, and president at Samsung Biologics, in a statement announcing the run’s completion.
As 2023 begins, Samsung Biologics will look to build on this success and pursue other mRNA contracts with companies developing innovative new therapeutics and vaccines.
The Future of mRNA Vaccine Production
The introduction of lipid nanoparticles was a major development in the advancement of mRNA vaccine production technology. These LNPs small fat particles used to. Coat the molecules of mRNA in a vaccine. For years, researchers had struggled to ensure the stability of mRNA molecules, but LNPs have helped prevent degradation. Once the LNP-coated mRNA injected into the body. It can instruct the immune system to produce proteins that target specific antigens, such as a COVID-19 virus or cancer cells.
Unlike traditional vaccines. MRNA vaccines can produced. Quickly through an in vitro process. They don’t need to grown in living cells. Samsung Biologics’ process involves the linearization of circular plasmid DNA molecules. Which then transcribed into mRNA, purified using enzymes, and encapsulated in LNPs. After producing this drug substance, the CDMO can provide aseptic fill/finish services, transferring the final drug product to the vaccine vial to sent to patients. Samsung Biologics utilizes precise clean room and cold storage facilities throughout this process to ensure stability.
“MRNA can be produced more rapidly by cell-free processes than other biological drugs, and it is readily standardized and scaled up, improving drug developer/manufacturer responsiveness to emerging outbreaks,” explained Pierre Catignol, executive vice president and head of manufacturing at Samsung Biologics.
“Production volume needs between vaccines and therapeutics differ significantly. Cancer vaccines and therapies targeting multiple solid tumors are projected to comprise the largest-scale commercial manufacturing projects. Infectious disease programs, meanwhile, require manufacturing at a lower scale. For efficiency, the platform process must be adjusted to accommodate these volume needs, such as [small activating RNA] and circular RNA (cirRNA), wherein a small quantity of material can support many doses.”
Next Steps for Samsung Biologics
Samsung Biologics designed its mRNA vaccine production suite to accommodate this variety of scales, meaning that it has the capabilities to partner with vaccine developers on projects ranging from cancer therapeutics to infectious disease vaccines. COVID-19 vaccines remain the only currently approved mRNA vaccines, but there’s a promising pipeline of research for applications such as personalized cancer vaccines and vaccines to prevent diseases such as Zika virus, influenza, and HIV.
In preparing to lead the way as a contract manufacturing partner for mRNA projects, Samsung Biologics is drawing on its track record of expertise in technology transfer and end-to-end manufacturing of monoclonal antibodies, according to Catignol.
“We have mRNA-dedicated teams and experts to answer all your questions and take care of your product. We have a full scope of services, and we have all flexible scales from laboratory to commercial. We can tailor according to your needs,” he said in a recent webinar. “We have a proven quality track record at the highest standard with more than 150 approvals from over 25 health authorities from our history of monoclonal antibodies.”
Rim has identified portfolio diversification as a key pillar of Samsung Biologics’ multidimensional growth plan moving forward, and mRNA vaccine production is an important part of this diversification effort. In addition, Samsung Biologics has ramped up its focus on biosimilars with the full acquisition of Samsung Bioepis in 2022, and at the 2023 J.P. Morgan Healthcare Conference held in January, Rim suggested that the CDMO could enter the cell and gene therapy market and construct a manufacturing facility for antibody-drug conjugates.
“We will maintain our lead in manufacturing capacity with the full completion of Plant 4 in mid-2023, and invest another 7.5 trillion won [approximately $5.95 billion] in Bio Campus 2,” said Rim. “We are also considering expanding our CDMO services to include ADC and gene therapy.”
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