How CDMO Samsung Biologics Ensures Safe mRNA Vaccine Production In sandbox

How CDMO Samsung Biologics Ensures Safe mRNA Vaccine Production

The COVID-19 pandemic was a catalyst for mRNA vaccine production. After years of research, mRNA vaccines were showing significant progress in the 2010s, but the unprecedented demand created by COVID-19 accelerated mRNA research and development. In 2021, the biopharmaceutical industry stepped up to produce mRNA COVID-19 vaccines, the first-ever mRNA vaccines for large-scale use. Samsung Biologics, a leading contract development and manufacturing organization (CDMO), played an essential role, providing fill/finish services for Moderna’s COVID-19 vaccine.

Safety was a primary concern as companies considered the best approach to mRNA vaccine production. Moderna turned to Samsung Biologics because of its reputation for ensuring safety and stability in aseptic fill/finish manufacturing. 

What is Fill/Finish Manufacturing?

Fill/finish is the final step in the drug manufacturing process. It’s a crucial step that involves transferring a sterile drug to a sterile container, ensuring no contamination throughout the process. Any breach in sterility could result in microbial contamination, placing an entire batch at risk.

This important step produces a drug in deliverable form. In the case of mRNA vaccine production, this means transferring an mRNA drug substance into a sterile vial.

Fill/finish manufacturing is a complex process that involves precise engineering of filling, dispensing, and sealing systems. Capable fill/finish facilities also need to employ comprehensive environmental monitoring programs; maintain meticulous clean room environments and around-the-clock temperature monitoring; and utilize precise storage condition controls to gauge temperature, humidity, and exposure to light.

Samsung Biologics’ Fill/Finish Capabilities

The foundation of Samsung Biologics’ fill/finish process is a dedicated manufacturing science and technology (MSAT) team for technology transfer and production. The MSAT team works closely with clients to assess primary packaging components. It also performs a thorough gap analysis and risk assessment of formulation and filling equipment, including contact surfaces, single-use system (SUS) assemblies, tubing, and filling needles.

Samsung Biologics can provide end-to-end fill/finish services, including early-phase formulation development, clinical filling, and high-volume commercial filling. It provides secondary packaging and labeling for monoclonal antibodies (mAbs) and mRNA products.  

Safety and stability are maintained throughout the fill/finish process with an extensive monitoring program for each commercial production process. Monitoring is based on a statistically significant number of batches agreed upon by Samsung Biologics and the client. In addition, Samsung Biologics utilizes its Enterprise Quality Unified Information System (EQUIS) to provide clients with real-time access to vital information on production processes and documentation in a shared format. This information can be securely viewed from anywhere and at any time to ensure continuous monitoring.

Fill/Finish Services for Moderna’s mRNA Vaccine

These advanced capabilities led Moderna to partner with Samsung Biologics to produce mRNA vaccines at Samsung Biologics’ facilities in Songdo, South Korea.

“Samsung Biologics was the first in Korea to perform fill/finish manufacturing of Moderna’s COVID-19 mRNA vaccine and obtain approval from the Korean Ministry of Food and Drug Safety (MFDS),” said Samsung Biologics CEO John Rim in a March 2022 letter to shareholders. “Samsung Biologics will continue to dedicate itself to providing a reliable supply of COVID-19 vaccines and treatments and contribute to the ending of the prolonged COVID-19 global pandemic.”

The partnership with Moderna involved utilizing Samsung Biologics’ aseptic fill/finish, labeling, and packaging services to support the production of hundreds of millions of doses of Moderna’s COVID-19 vaccine for the supply of markets outside of the U.S.

The Future of mRNA Vaccine Production

The success of mRNA vaccine production for COVID-19 vaccines has led to optimism in the biopharmaceutical industry about the potential of mRNA vaccines for other applications.

“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,” said James Choi, Samsung Biologics’ executive vice president and chief information and marketing officer, in a recent interview with the European Pharmaceutical Review.

As the industry explores new avenues for developing mRNA vaccines to save patients’ lives, Samsung Biologics is expanding its mRNA capabilities beyond fill/finish manufacturing. The CDMO added a facility at its Songdo headquarters that provides end-to-end mRNA vaccine production services, adding drug substance capabilities to its drug product services. . This will result in shorter timelines for completing the mRNA vaccine production process.

Samsung Biologics’ new facility began manufacturing GreenLight Biosciences’ COVID-19 vaccine candidate as part of an agreement the companies announced in November 2021.

mRNA vaccine production played a key role in Samsung Biologics’ continued growth in 2021, with the company experiencing a 35% increase in revenue. Now, Samsung Biologics is planning to build on this success by making mRNA a pillar of its plans for what Rim calls “multidimensional growth.”

Samsung Biologics’ role as a fill/finish provider for COVID-19 mRNA vaccines demonstrated the CDMO’s capacity and robust business operations. With its plans to expand mRNA capabilities, the company is building on its mRNA success to expand its portfolio.

"As part of our vision, we are now venturing into the three core pillars of our multidimensional growth plan, encompassing expanded manufacturing capacity, continued advancements in business portfolio, and greater global footprint," said Rim in his address to shareholders in March. "As a leading CDMO service provider, we will continue to demonstrate our excellent business operations throughout our value chains to ultimately contribute to saving the lives of patients and build a better future for all.”

 

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