Samsung Biologics, one of the world’s largest contract development and manufacturing organizations, has made international expansion a priority as part of its “multidimensional growth plan.” The Korea-based CDMO, which already operates a research and development center in San Francisco, recently announced the opening of a sales office in Ridgefield Park, New Jersey. The new office will streamline communication with clients in the U.S. and Europe and facilitate opportunities for CDMO partnerships.
“The sales office will allow Samsung Biologics to establish a permanent communication channel in a place with high geographical accessibility to customers and increase satisfaction,” said Samsung Biologics president and CEO John Rim at the 2023 J.P. Morgan Healthcare Conference.
The opening of the New Jersey office comes amid a period of rapid expansion for Samsung Biologics, the biotech unit of Samsung Group. In recent years, more pharmaceutical companies are turning to CDMOs to outsource manufacturing, allowing them to focus resources on developing new drugs.
Samsung Biologics has been at the forefront of this trend, quickly becoming an industry leader in manufacturing capacity after its establishment in 2011. In 2022, Rim announced the CDMO’s multidimensional growth plan, which consists of three pillars: portfolio diversification, increased capacity, and an expanded global footprint.
As the San Francisco and New Jersey offices make progress on the third pillar, Samsung Biologics has made large strides on the first two, with several new capabilities and facilities added recently. Several more have been announced for future development.
In 2022, Samsung Biologics added an end-to-end mRNA vaccine production suite at its headquarters in Songdo, South Korea. After providing fill/finish services for Moderna’s COVID-19 mRNA vaccine, the CDMO expanded its capabilities to include drug substance services. It can now produce the mRNA needed for vaccines at the same facility where it transfers it to vials, then packages and labels the final product.
Samsung Biologics also invested in biosimilars in 2022, completing a full acquisition of Samsung Bioepis, which had been run as a joint venture between the CDMO and Biogen since 2012. Samsung Bioepis has already established popular biosimilars for immunological and oncological applications, and it is developing several other medicines in areas such as ophthalmology, hematology, endocrinology, and gastroenterology.
Samsung Bioepis recently received FDA approval for a biosimilar that references Humira (adalimumab), the world’s most prescribed drug. Humira treats autoimmune conditions such as rheumatoid arthritis,
psoriasis, ulcerative colitis, and Crohn’s disease. With Humira’s patent set to expire, there is an opportunity to provide alternatives in the biosimilars
“From a portfolio perspective, we have the broadest biosimilar portfolio with 10 products,” said Rim.
In addition to its recent portfolio expansion, Samsung Biologics expanded its manufacturing capacity in 2022 with the launch of partial operations at its fourth manufacturing plant.
The plant was partially operational just 23 months after construction began in November 2020. It is scheduled to be fully operational in 2023, adding 240,000 liters of manufacturing capacity, the most of any single facility in the world, according to Rim. This will bring Samsung Biologics’ world-leading capacity to a total of 604,000 liters. The CDMO has already secured several contracts for Plant 4 and will look to continue using the new facility as a growth driver in its primary business of monoclonal antibody manufacturing.
Samsung Biologics also recently announced plans to begin construction on Plant 5 at the CDMO’s new Bio Campus 2. In July 2022, Samsung purchased 357,366 square meters (about 88.3 acres) in the Incheon Free Economic Zone for the construction of the new campus. The land is 30% larger than that of the CDMO’s first Bio Campus.
“The company plans to invest a total of 7.5 trillion [South Korean] won (about $6 billion) in constructing four new plants and a bio innovation center to nurture promising companies related to next-generation medicines,” said Rim.
In a press release announcing plans to begin constructing Plant 5, the CDMO explained that it is expected to commence operations in 2025, encompassing an area of 96,000 square meters and adding another 180,000 liters of manufacturing capacity to bring Samsung Biologics total to 784,000.
“Given the continuing increase in the demand for outsourced manufacturing of biopharmaceuticals, we are proactively making this investment in alignment with our growth strategy to further strengthen our standing as a leading CDMO,” said Rim in the release. “The new facility will enable us to provide our customers with even greater innovation and services that will increase speed to market and flexibility.”
What’s Next for the CDMO?
Rim also discussed the CDMO’s plans to enter new business areas in the coming year. He said that the company is considering investing in both antibody-drug conjugates and cell and gene therapies.
Samsung Biologics will be building a new ADC facility in Incheon, and it has already invested in biotech companies through the Life Science Fund it operates with Samsung C&T. In 2022, the fund invested in Jaguar Gene Therapy, which focuses on accelerating gene therapy for patients suffering from genetic disease, and Senda Biosciences, which focuses on deconstructing nature’s genetic codes to program information molecules and nanoparticles.
“Samsung has had phenomenal organic growth, such as investing in Bio Campus 2, continuing to build new plants, operating our CDO business, expanding our sales offices, and advancing new technologies,” said Rim.