A new report predicts the mRNA vaccine market will grow at a compound annual growth rate of 7.2% over the period spanning 2022 to 2027. While the rapid growth of the mRNA market in 2021 was due to the production of COVID-19 vaccines, the first approved for human use, the market is expected to grow through innovation in upcoming years, with vaccines in development for several new non-COVID applications.
Against this backdrop, Samsung Biologics, one of the world’s largest contract development and manufacturing (CDMO) organizations, is investing in expanded mRNA vaccine production capabilities, building a new end-to-end mRNA suite with drug substance and drug product capabilities.
“Samsung Biologics is committed to offering end-to-end services and facility capability for multiple modalities, including mRNA technology,” said Pierre Catignol, executive vice president and head of manufacturing at Samsung Biologics, in a recent Q&A. “We have served numerous clients from pDNA to vial, including in-house analytical and stability testing capability provided by a dedicated [manufacturing science and technology] lab. Our services include the manufacture of mRNA drug substance, formulated bulk drug product manufacturing (encapsulation), and fill/finish — all from a single site.”
Catignol and Huisub Lim, Samsung Biologics’ lead scientist in mRNA manufacturing, are optimistic about the future of mRNA vaccine production for both COVID and non-COVID applications, explaining that mRNA vaccines and therapeutics have potential applications ranging from cancer to infectious diseases such as influenza, Zika virus, and HIV.
The report made a similar point, noting that “Non-COVID-19 mRNA vaccines for HIV, influenza, and other viral infections are currently in development and clinical trials. For example, in April 2022, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), launched a Phase 1 clinical trial to evaluate three experimental messenger RNA (mRNA)-based HIV vaccines.”
MRNA Vaccine Production at Samsung Biologics
Samsung Biologics first became involved in mRNA vaccine production when it partnered with Moderna in 2021 to provide aseptic fill/finish services for Moderna’s COVID-19 vaccine.
The CDMO then decided to build on these drug product capabilities, adding drug substance services in April 2022 to create a one-stop-shop mRNA vaccine production suite. Samsung Biologics can now manufacture the mRNA molecules needed for vaccines, as well as the lipid nanoparticles that coat mRNA in vaccines and ensure stability. The end-to-end mRNA vaccine production process involves linearizing circular plasmid DNA (pDNA), transcribing it into mRNA molecules, then purifying these molecules using enzymes and coating them with LNPs using precise pump-mixing technology. Once the molecules are purified and encapsulated, the drug substance is transferred to vials in an aseptic process in clean room environments, then stored at temperatures as low as minus 70 degrees Celsius in Samsung Biologics’ cold-chain storage facilities.
Because Samsung Biologics can provide all of these services at a single facility, it can reduce time lines and mitigate the risk of degradation that can arise when transporting mRNA and related materials.
“Few manufacturers/CDMOs are adequately equipped or capable of carrying out all manufacturing steps, leading to logistical, monetary, and time line difficulties. Frequent handling of mRNA across multiple locations increases contamination and degradation risks,” said Catignol. “When the entire work stream is coordinated by one partner, from a single location, transitions across development and production tasks run smoothly, maximizing efficiency and mitigating potential risks.”
Thus far, Samsung Biologics, like all other pharmaceutical companies, has only utilized its mRNA vaccine production capabilities for COVID-19 applications, but its successful completion of a commercial-scale run for GreenLight Biosciences’ COVID-19 vaccine in July demonstrated the potential of its end-to-end approach. The partnership’s first production run was completed just seven months after the initial technology transfer, producing 650 grams of mRNA at a titer of 12 grams per liter.
“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur in a press release announcing the production run. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.”
One of the key competencies required to produce mRNA vaccines for a variety of applications is scalability, as cancer vaccines and infectious disease vaccines will require very different quantities of mRNA, and demand may dictate smaller or larger batches of either type of vaccine. As a CDMO, Samsung Biologics’ business revolves around partnering with other pharmaceutical companies to produce their biologic medicines, and it prides itself on being adaptable to the needs of both large and small companies. When constructing its mRNA vaccine production suite, Samsung Biologics emphasized the need for scalability, as Catignol explained in a recent webinar. The goal was to apply the CDMO’s philosophy of scalable, end-to-end production of monoclonal antibodies, its main business, to mRNA vaccine production.
“We can produce from milligrams for preclinical and Phase 1, up to grams for clinical stage, up to hundreds of grams … That means Phase 3 commercial scale in a GMP manufacturing facility,” said Catignol. “We have an mRNA laboratory that is already in operation. This mRNA laboratory allows us to leverage our great experience during the last 10 years in tech transfer process development and characterization. Mainly, all these competencies have been acquired for monoclonal antibodies.”
New Horizons for mRNA
In a recent report by the NIH on the potential of personalized cancer vaccines, Karine Breckpot, an mRNA researcher at the Vrije Universiteit Brussel in Belgium, explained how mRNA can direct the body to attack cancer cells after being taken up by dendritic cells, an immune cell found in tissues such as the skin.
“Dendritic cells act as teachers, educating T cells so that they can search for and kill cancer cells or virus-infected cells,” she explained.
“Unfortunately, it took a pandemic for there to be broad acceptance of mRNA vaccines among the scientific community,” she added. “But the global use of COVID-19 mRNA vaccines has demonstrated the safety of this approach and will open doors for cancer vaccines.”
Samsung Biologics is looking to build on the research community’s consensus on the viability of mRNA vaccines, providing the manufacturing services needed to realize the innovative solutions likely to be developed in the future.