During the COVID-19 pandemic, millions of messenger RNA (mRNA) vaccines were administered to individuals around the globe. Demand for these lifesaving vaccines was understandably high, and the biopharma industry stepped up to meet demand. Samsung Biologics, one of the world’s largest contract development and manufacturing organizations (CDMOs), played a central role in mRNA vaccine production during the pandemic. Now, the CDMO is investing revenue earned during the pandemic into manufacturing facilities for the next generation of innovative biologic medicines, including affordable biosimilars and mRNA vaccines for other diseases.
Meeting Demand for mRNA Vaccine Production
Before the COVID-19 pandemic, research in mRNA vaccine development was reaching a turning point and showing more promise than it had in previous years. After decades of research on methods for successfully preserving and delivering fragile mRNA molecules for therapeutic applications, technology that utilized lipid nanoparticles to deliver mRNA was showing unprecedented success. But despite this promising research, no one expected the accelerated time lines and global demand for mRNA vaccines caused by the onset of COVID-19.
Fortunately, when the need arose for a vaccine to fight the novel virus, companies such as Pfizer and Moderna were able to expedite their development of mRNA technology and create successful COVID-19 vaccines. However, the global spread of the pandemic required mRNA vaccine production at a massive scale. Biopharma companies needed to turn to CDMOs to meet this demand.
This is where Samsung Biologics was able to aid the vaccination effort, utilizing its significant manufacturing capabilities to provide fill/finish services for Moderna’s COVID-19 vaccine. In addition, in November 2021, Samsung announced it will produce GreenLight Bioscience’s COVID-19 mRNA vaccine candidate, currently in third-stage clinical trials, at a large scale.
While the pandemic posed challenges to many industries, Samsung Biologics was able to implement a strategic risk mitigation approach to ensure it continued to operate at the highest level to provide vaccines.
“As soon as the COVID-19 pandemic occurred, we really focused around making sure that our supply chain and raw materials were robust,” said Samsung Biologics CEO John Rim in a recent interview. “We’ve also operated our plants 365 days, 24/7, because we have strict protocols and business continuity management systems that enable us to manage through the COVID pandemic without a hitch.”
With these strategies and protocols in place, Samsung Biologics was able to generate opportunities for growth while supplying patients with the therapies they need. Now, the CDMO is focused on using this growth opportunity to expand its capabilities and foster innovation in the development and manufacture of other helpful biologic medicines.
Pursuing Innovation in Biologics
Samsung Biologics’ revenue increased by 35% amid surging demand for contract manufacturing in 2021, and it plans to continue to expand to meet this demand.
The company, which is based in South Korea, is pursuing overseas facilities to ensure it can continue to supply biologic medicines around the globe.
“The COVID situation has highlighted more of the need to diversify and risk-manage, particularly around supply chain management. It has also highlighted the need for doing things quickly,” said Rim in an interview with The Financial Times.
In addition to overseas facilities, Samsung Biologics is building on its industry-leading manufacturing capabilities in South Korea with the construction of its Plant 4 in Songdo. The “Super Plant” is designed for large capacity and flexible scale, and upon its completion in early 2023 it will be the world’s largest biopharmaceutical manufacturing facility of its kind.
A key element of expanding its capacity is Samsung Biologics’ commitment to mRNA vaccine production. While its partnership with Moderna already demonstrated its robust mRNA drug product capabilities, Samsung Biologics is now expanding its capabilities to include mRNA drug substance manufacturing. This means the CDMO can provide end-to-end mRNA vaccine production, from bulk drug substance to aseptic fill/finish, including labeling and packaging, as well as cold chain storage.
These increased capabilities come as innovations in mRNA technology are leading to several promising applications for mRNA vaccines, including treating infectious diseases such as influenza, Zika virus, and rabies, and modulating antigen-specific T-cell responses to fight cancer.
“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 James Choi, Samsung Biologics’ executive vice president and chief information and marketing officer, in an interview with the European Pharmaceutical Review.
In addition to expanded mRNA capabilities, Samsung Biologics is investing in the development of affordable biologic medicines. It recently acquired full ownership of Samsung Bioepis, which was founded as a joint venture by Samsung Biologics and Biogen. Samsung Bioepis focuses on the development of biosimilars: biologics that meet the same quality, safety, and efficacy standards of a reference medicine but can provide a cost-effective alternative.
In just 10 years of operation, Samsung Bioepis has received global approval for a total of six biosimilars: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab, and ranibizumab. Its seventh biosimilar, eculizumab, recently completed phase-three clinical trials. Three additional biosimilars are currently under phase three clinical trials. In acquiring Biogen’s 50% stake in the company and assuming full ownership, Samsung Biologics is advancing its capabilities in novel drug development.
“Our next decade will be marked by increased business expansion and portfolio diversification. While continuing to achieve best-in-class CDMO services and championing the biosimilar business, we will also lay the groundwork for novel drug development, to ultimately become a full-service biopharmaceutical company,” explained Rim at the January 2021 JP Morgan Healthcare Conference.
After responding to the challenge of mRNA vaccine production during the COVID-19 pandemic, Samsung Biologics is poised to continue as a leader in the biopharma industry, developing, manufacturing, and improving patient access to innovative biologic medicines.
Dil Bole Oberoi
