Samsung Biologics, a leading contract development and manufacturing organization (CDMO), held its 11th Annual General Meeting of Shareholders (AGM) on March 28, 2022. At the meeting, Samsung Biologics CEO John Rim summarized the company’s growth in 2021 and outlined a “multidimensional growth plan” for future development across the company’s three core pillars: increasing CDMO capacity, enhancing portfolio diversification, and expanding its global footprint.
A Productive 2021
In a letter to shareholders, Rim recapped Samsung Biologics’ key activities and milestones from 2021 and discussed how these fit into the CDMO’s ambitious plans for future growth.
Samsung Biologics played an important role in the global supply of COVID-19 vaccines in 2021, utilizing its substantial manufacturing capacity to partner with Moderna to fill/finish mRNA COVID-19 vaccines.
“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. 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,” said Rim.
As a CDMO, Samsung Biologics has both drug development and manufacturing operations. While its role in mRNA vaccine production in 2021 was on the manufacturing side, the company also made advancements in its drug development capabilities, launching the S-Cellerate™ drug development platform.
Rim explained that S-Cellerate™ was designed to “offer clients an integrated and seamless drug development solution resulting in accelerated timelines, improving both economics and convenience.”
Fueled by increasing CDMO demand during the COVID-19 pandemic, Samsung Biologics experienced significant profit growth in 2021, reporting a revenue increase of 35%. The company also increased its employment rate by 37% in 2021, keeping pace with its annual employment increase rate of 43% since its establishment in 2011.
This growth comes as Samsung Biologics took several steps to commit to sustainable development in 2021. It released its first-ever sustainability report and developed an enhanced Environmental, Social, and Governance (ESG) management system, which included the establishment of an ESG Committee. In addition, Samsung Biologics was recognized with an “A” ESG rating from the Korea Corporate Governance Services and became the first Korean pharmaceutical company to be added to the Dow Jones Sustainability World Index.
Samsung Biologics’ 2021 has set the stage for what Rim called a “multidimensional growth plan.” Several plans for future growth were outlined in Rim’s letters to shareholders. The plans were divided into three categories:
1.) CDMO Capacity
Samsung Biologics currently operates three large plants in Songdo, South Korea, and its Plant 4 is now under construction, with plans to start partial operations in Q4 2022 and operate at full capacity by mid-2023, six months ahead of the original schedule. With an expected capacity of 256,000 liters, Plant 4 will be the largest CDMO facility in the world, and it will bring Samsung Biologics’ expected total manufacturing capacity to 620,000 liters.
The company is currently in the process of planning manufacturing activities for the plant.
“We have already secured CMO contracts for five different products with three global companies for Plant 4 as a result of steady pre-sales activities,” said Rim.
In addition to Plant 4, Rim noted Samsung Biologics’ plans to purchase land for the construction of a Bio Campus II facility in 2022. Rim explained that the facility is expected to have a landmass 30% greater than the company’s current Bio Campus I facility in Songdo. It will serve as the site for construction of future large-scale plants and an Open Innovation Center.
While it continues to develop its primary business as an antibody CDMO, Samsung Biologics is actively expanding its portfolio and capabilities.
The company recently acquired full ownership of Bioepis, which was started as a joint venture with Biogen in 2012. With the acquisition, Samsung Biologics plans to strengthen its capabilities in the development of biosimilars, which offer cost-effective alternatives to biologic reference medicines. Bioepis has successfully launched five biosimilars globally, in addition to one recently approved biosimilar and four currently in Phase 3 clinical trials. The company has focused on immunology and oncology applications and is expanding into ophthalmology, hematology, gastroenterology, and endocrinology.
““Today’s announcement marks a significant milestone for Samsung Biologics in our continued venture into the biosimilar business and accelerating biosimilar growth. By leveraging our extensive experience as a leading CDMO, we will further contribute to saving lives of the patients and address a wide array of diseases,” said Rim.
Samsung Biologics is also expanding its mRNA vaccine production capabilities, adding drug substance manufacturing to its drug product manufacturing capabilities. Rim explained that the company is adding an mRNA drug substance manufacturing facility, expected to be ready for current Good Manufacturing Practices operations within the first half of 2022. The facility will offer end-to-end manufacturing for mRNA vaccines and therapeutics and is scheduled to begin manufacturing GreenLight Biosciences’ mRNA COVID-19 vaccine candidate.
Samsung Biologics continues to expand at its headquarters in South Korea, and it’s also exploring options to establish more operations worldwide. This process began when Samsung Biologics launched a research and development center in the San Francisco biotech cluster in 2020, and the CDMO is currently exploring options to launch additional facilities in the U.S. and Europe in an effort to meet increasing global demand for its services.
Building a Better Future
Ultimately, Rim emphasized that Samsung Biologics’ growth will benefit patients as the biopharma industry continues to innovate in both development and manufacturing capabilities.
“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,” said Rim.