In January, Samsung Biologics, a global contract development and manufacturing organization, disclosed impressive financial outcomes for both the fourth quarter and the entire fiscal year of 2023. The CDMO surpassed 1 trillion South Korean won (roughly $746 million) in consolidated operating profit for the first time since its inception in 2011, marking what it called a “decade of operational excellence.”
And no less than 14 out of the top 20 global pharmaceutical companies sat up and took notice.
John Rim, president and CEO of Samsung Biologics, attributed the company’s financial growth to several strategic initiatives and expansions, including the successful completion and operation of its Plant 4 facility in June 2023.
“Our unwavering commitment to customer-centric services and continuous innovation remains at the core of our mission, ensuring the delivery of high-quality biomedicines to patients worldwide,” said Rim in a statement on Samsung Biologics’ final earnings report for 2023. “Despite the challenging environment, we remain optimistic, anticipating continued growth driven by sustained partnerships, expanded capacity, and strategic portfolio diversification in the coming year.”
As of the end of 2023, the CDMO had secured contracts valued at over $12 billion, including partnerships with 14 of the most prominent 20 global pharmaceutical companies.
At the core of Samsung Biologics’ success is its cell line development platform, which includes technologies designed to enhance productivity and quality in the development process, allowing for the efficient production of biologic medicines. Such capabilities enable Samsung Biologics to meet the diverse and complex needs of a range of global biopharmaceutical companies, offering them customized solutions that align with their specific project goals.
Samsung Biologics’ Cell Line Development Platform
Samsung Biologics’ cell line development platform involves culturing and genetically altering collections of cells to make them capable of producing therapeutic proteins, such as monoclonal or bispecific antibodies, in substantial quantities. The cornerstone of this system is S-CHOice®, which employs Chinese hamster ovary cells modified with glutamine synthase knockout technology, facilitating a development process that enhances production titers and cell viability.
The S-CHOice® platform is distinguished by its ability to generate biologic concentrations exceeding 7 g/L for standard monoclonal antibodies. This capability is coupled with a demonstrated ability to maintain cell viability above 90% over 20 days. Samsung Biologics’ incorporation of the Beacon system, which allows for precise single-cell cloning, drastically improved the efficiency of selecting highly productive cell lines.
Further augmenting its suite of technologies, Samsung Biologics integrates the S-CHOsient™ platform for transient gene expression, essential for the early stages of cell line development, and the DEVELOPICK™ technology for high-throughput screening of cell viability and productivity.
Samsung Biologics’ Partnerships
Samsung Biologics’ use of cell line development to accelerate development timelines, improve product purity, and produce therapeutics at commercial scales has drawn companies of various sizes to partner with the CDMO.
One standout partnership in 2023 was with Pfizer, one of the world’s leading pharmaceutical enterprises. In July, Samsung Biologics signed drug manufacturing deals worth $897 million with Pfizer for the production of biosimilar products. These contracts are a testament to Samsung Biologics’ manufacturing capabilities, particularly highlighting the role of Plant 4, which boasts the world’s largest biomanufacturing capacity for a facility of its kind at 240,000 liters. The agreements cover several of Pfizer’s biosimilar products across oncology, inflammation, and immunotherapy, with the largest single contract valued at $704 million. This partnership reflects the industry’s trust in Samsung Biologics’ production capacity, speed, and quality, and it significantly contributed to the company’s growing order intake last year.
In October 2023, Samsung Biologics announced a strategic partnership with Kurma Partners, a European venture capital firm specializing in health care and biotechnology. This multiyear agreement will see Samsung Biologics offering development, de-risking, and manufacturing services to Kurma Partners’ portfolio companies, facilitating the transition from early-stage development to large-scale commercialization. The collaboration is designed to streamline the investigational new drug process, and is part of Samsung Biologics’ further expansion of its business presence into the European market.
Samsung Biologics also continues to work with up-and-coming biotech startups. Aronora, a Portland, Oregon-based company focused on developing treatments for blood clotting diseases, leveraged S-CHOice® to significantly enhance the titer of its cell line, crucial for the commercial viability of their monoclonal antibody, Gruticibart.
“Cell line development is the foundation for everything,” said Christina Lorentz, director of clinical operations at Aronora. “One of the best things about this collaboration has been Samsung’s experience going from cell line development all the way to commercialization. As a small company, we have really benefited and learned a lot about the entire process as opposed to just looking at it piece by piece. We are truly in good hands with Samsung.”
In another project, Bolt Biotherapeutics, which is developing a novel cancer treatment, faced a critical challenge when an unexpected impurity emerged. Through transparent communication and collaborative problem-solving, Samsung Biologics and Bolt addressed the issue without delaying the timeline, demonstrating the importance of trust and open dialogue in CDMO partnerships.
“The way Samsung is building new plants and adding capacity in the future gives us the confidence that a year or two from now, there will be adequate capacity, if our project is successful, for us to continue to work together,” said Nathan Ihle, senior vice president of pharmaceutical operations at Bolt Biotherapeutics. “We are very hopeful for a long and positive future together with Samsung Biologics.”
