Samsung Biologics, a leading contract development and manufacturing organization (CDMO), is adding messenger RNA (mRNA) vaccine drug substance manufacturing capabilities at its facility in Songdo, South Korea, in 2022. The enhanced capabilities will enable Samsung Biologics to provide seamless, end-to-end mRNA vaccine production at the facility.

Samsung Biologics was already manufacturing mRNA vaccine products, but by manufacturing the drug substances needed for those products at the Songdo facility, rather than receiving them from another facility, the company can eliminate potential contamination and degradation risks, maximize efficiency, and expedite time to market for mRNA vaccine production.

Drug Substance and Drug Product Manufacturing

While drug substance and drug product manufacturing may sound similar, they are distinct processes involved in manufacturing biopharmaceuticals such as mRNA vaccines.

Drug substance manufacturing involves the production of the active ingredient in the drug product, while drug product manufacturing involves producing the final dosage form of the drug, like vaccines. The active ingredient is often, but not necessarily, combined with inert materials known as excipients in the final drug product.

In terms of mRNA vaccine production, the required drug substances are often produced at a separate facility, frozen, and shipped to a CDMO for drug production. However, Samsung Biologics’ mRNA drug substance production capabilities will allow the company to offer a one-stop solution  and produce mRNA vaccines faster without delays.

The enhanced capabilities enable the Songdo facility to handle all aspects of the mRNA vaccine production process, from bulk drug substance production to aseptic fill/finish.

What Are mRNA Vaccines and How Are They Produced?

Traditional vaccines involve introducing a version of a virus to the body’s immune system to trigger the body to produce antibodies. By contrast, an mRNA vaccine works by introducing genetic material that instructs cells to make a specific protein involved in an immune response to a particular illness, from COVID-19 to cancer.

Producing mRNA is a cell-free process that involves linearization of plasmid DNA (pDNA). The pDNA is mixed with enzymes and nucleotides to allow for its transcription into mRNA, then purified in steps involving chromatography, ultrafiltration (UF), and diafiltration (DF). Samsung Biologics will be able to execute this stage of drug substance development and move quickly to the drug production process of manufacturing vaccine doses.  

Growing Demand for mRNA Vaccine Production

Samsung Biologics’ expansion of mRNA vaccine production capabilities comes amid growing demand for mRNA vaccines for a variety of applications.

Following the onset of the COVID-19 pandemic, mRNA vaccines received worldwide attention, as mRNA technology was used to develop successful COVID-19 vaccines. Samsung Biologics played a leading role in this process, working with several partners to satisfy demand for increased mRNA vaccine production. For example, Samsung Biologics partnered with Moderna in May 2021 to supply the commercial fill/finish manufacturing services for Moderna’s mRNA COVID-19 vaccination.

Additionally, in November 2021 Samsung Biologics announced a partnership with Boston-based RNA company GreenLight Biosciences to manufacture GreenLight’s mRNA COVID-19 vaccine candidate at a large scale. The increased production will help more vaccines reach individuals in developing countries where access has been limited. Samsung Biologics’ partnership with GreenLight aligns with the goal of helping to vaccinate the world against COVID-19. It also aligns with calls by the Coalition for Epidemic Preparedness Innovations (CEPI) to increase global vaccine manufacturing capacity not just for COVID-19, but for all infectious diseases that threaten global public health.

In pursuing advanced mRNA vaccine production capabilities over the course of the COVID-19 pandemic, Samsung Biologics has also positioned itself to manufacture other mRNA therapeutics. James Choi, Samsung Biologics’ Executive Vice President and Chief Information and Marketing Officer, explained the broader significance of mRNA vaccine production in an interview with the European Pharmaceutical Review. 

“The use of mRNA technologies in the production of vaccines in response to COVID-19 has demonstrated the effectiveness and potential of the technology,” said Choi. “The capability for mRNA to be easily edited not only makes it the ideal tool to combat viruses that can quickly mutate, but also gives it the potential to be used in the treatment of countless other diseases. This is highlighted by the fact that there were over 70 mRNA therapeutics in clinical pipelines globally as of July 2021, and there are many more assets currently in early development.”

Innovation in mRNA Vaccine Production

The development of mRNA vaccines against COVID-19 led to increasing demand for mRNA vaccine production, and COVID-19 vaccinations will likely remain a key application of mRNA technology, particularly with the need for booster vaccinations. However, there are several other promising applications of the technology. According to a review of mRNA vaccine research by Nature, mRNA vaccine technology is showing positive results in areas as varied as immunizing against infectious diseases such as influenza, Zika virus, and rabies, to modulating antigen-specific T-cell responses to fight cancer.

These successes have coincided with technological innovations overcoming concerns about mRNA’s instability, high innate immunogenicity, and inefficient in vivo delivery. Researchers have long understood the unique therapeutic potential of mRNA, including its capacity for more rapid development and its application for non-infectious diseases like cancer, but in recent years technology has accelerated in enabling the realization of these benefits. For example, Samsung Biologics’ mRNA vaccine production technologies include cold storage to store mRNA at temperatures as low as minus 70 C, as well as precise pump mixing technology that encapsulates mRNA in lipid nanoparticles (LNPs) to prevent degradation and allow for in vivo delivery.

Capabilities To Produce the Vaccines of the Future

Research into applications of mRNA vaccines continues to advance, and as mRNA vaccine production technology improves in conjunction with this research, the biopharmaceutical industry is making significant progress in realizing the potential of mRNA vaccines. With its expanded mRNA drug substance manufacturing capabilities and commitment to innovative mRNA vaccine production, Samsung Biologics is leading the way for CDMOs in this promising space.