MRNA vaccines have protected hundreds of millions of people from COVID-19. After years of research, the pandemic galvanized the health care industry to produce the first mRNA vaccines approved for human use. The large-scale mRNA vaccine production required to combat a global pandemic led to an industrywide push to develop new capabilities — and contract development and manufacturing organizations (CDMOs) were tapped to meet demand.
Samsung Biologics, one of the world’s largest CDMOs, stepped up to provide fill/finish services for Moderna’s vaccines. Now, the CDMO has expanded its mRNA vaccine production capabilities as the research community is pursuing new applications for mRNA technology.
The National Institutes of Health has noted that the influx of funding and attention to mRNA technology during the pandemic is having a positive impact on research into non-COVID applications, particularly personalized cancer vaccines.
“There’s a lot of enthusiasm around mRNA right now,” said Patrick Ott, director of the Center for Personal Cancer Vaccines at the Dana-Farber Cancer Institute, in a recent NIH report. “The funding and resources that are flowing into mRNA vaccine research will help the cancer vaccine field.”
With dozens of clinical trials underway for mRNA cancer vaccines, the hope is that the pharmaceutical community can leverage the rapid development spurred by the pandemic to treat diseases ranging from cancer to HIV. Samsung Biologics has expanded its mRNA vaccine production capabilities with this bright future in mind, providing end-to-end drug substance and drug product services in a single facility that can handle vaccine production from laboratory to commercial scales.
“From what I have observed and what we can see in the market, the global mRNA vaccines and therapeutics market is forecasted to grow steadily in the next few years,” said Pierre Catignol, executive vice president and head of manufacturing at Samsung Biologics in a recent Q&A.
“This is largely because mRNA can create therapeutics based on a novel mechanism of action for applications that cannot be targeted by existing antibody platforms (e.g., gene editing, targeting of intracellular protein or pathogens, etc.). MRNA technology also is conducive to highly specific molecular designs and functionalities, giving it the potential to achieve greater efficacy than traditional drugs by addressing the underlying causes of disease.”
Meeting mRNA Vaccine Production Challenges
As Catignol explained, one of the challenges facing mRNA vaccine production is that different applications require different manufacturing scales. For example, more broadly applicable cancer vaccines that target multiple tumors may require larger batches, but on the other end of the spectrum, manufacturers may need to produce just a single personalized cancer vaccine uniquely designed for an individual patient.
“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 — but come with high clinical uncertainty. Infectious disease programs, meanwhile, require manufacturing at a lower scale,” said Catignol. “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. Smaller-scale production is necessary to serve the non-COVID and clinical-stage pipeline.”
A CDMO equipped to partner with pharmaceutical companies on a variety of mRNA vaccine production projects needs to be able to accommodate this range of scales without sacrificing quality or efficiency.
“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 [good manufacturing practice] manufacturing facility,” explained Catignol in a recent webinar on Samsung Biologics’ mRNA vaccine production capabilities.
Other challenges facing mRNA vaccine production include cold-chain storage and the development of lipid nanoparticles. The process of ensuring that mRNA molecules remain stable long enough to have the desired effect involves coating them in LNPs and storing them at precise temperatures.
To address these challenges, Samsung Biologics provides upright and walk-in storage systems with temperatures as low as minus 70 degrees Celsius. And with the expansion of its drug substance mRNA services, the CDMO is now able to produce LNPs in-house and coat mRNA molecules using precise pump mixing technology. This in-house capability helps mitigate the risk of degradation from transporting materials, and it can help defray the costs and bottlenecks that can be involved in ordering LNPs from an outside provider.
“Current restrictions in LNP technology create bottlenecks due to low production capability. Current on-market products have never been scaled up,” explained Catignol. “LNP encapsulation is a complicated process that must take place under certain conditions. It requires sterile conditions of an RNase-free environment in preparation, storage, and administration since LNPs themselves are unstable at room temperature, with a tendency to merge into a single particle. Further, mRNA must be immediately processed following LNP encapsulation.”
A Bright Future for mRNA
While the challenges facing mRNA vaccine production had stalled innovation in mRNA research and development for decades, COVID-19 sparked a revolution in mRNA, and researchers are optimistic about the viability of mRNA vaccines and therapies for conditions ranging from cancer to HIV, influenza, and Zika virus. This optimism is due to advances in mRNA coding, many of which have been facilitated by artificial intelligence, but it’s also due to manufacturing advances such as those represented by Samsung Biologics’ new end-to-end suite.
The industry is nearing a point at which it has both the scientific backing and the manufacturing strength to realize the potential of mRNA vaccines. CDMOs like Samsung Biologics will play a significant role in realizing this potential, applying lessons learned during the pandemic to advance agile biologic manufacturing techniques.
“CDMO competition can be expected to intensify since mRNA manufacturing capacity and CDMOs’ capabilities both expanded significantly to meet the need associated with the pandemic,” said Catignol. “This paradigm demands that CDMOs add value beyond capacity to stand out as optimal partners.”
For Samsung Biologics, adding value comes in the form of end-to-end mRNA vaccine production capabilities grounded in a history of successful technology transfers and manufacturing partnerships in monoclonal antibodies.
As Catignol explained, “This mRNA laboratory allows us to leverage our great experience during the last 10 years in tech transfer process development and characterization.”
The momentum in mRNA vaccine research and development should play a significant role in the biopharmaceuticals market in coming years, and with its expanded mRNA vaccine production capabilities, Samsung Biologics is positioned as a key market player.
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