Samsung Biologics has carved out a significant position in the contract development and manufacturing organization landscape. A significant factor in the company’s rise is its expertise in cell line development and monoclonal antibody production.
Charting the course of Samsung Biologics’ growth requires an understanding of why clients choose this platform, as well as the company’s aggressive expansion strategy and focus on monoclonal antibodies.
What Is Cell Line Development?
Cell line development is a critical process in biopharmaceutical manufacturing. It involves the creation of cell cultures that can produce the biological molecules needed for drug development.
Cell lines can be derived from mammals, insects, bacteria, or yeast, but the most common cells used are from Chinese hamster ovaries (CHOs). These cells were derived from an organism decades ago, but can now be replicated in vitro in the lab.
Samsung Biologics’ cell line is based on CHOs and uses a glutamine synthase knock-out system that inactivates an enzyme involved in various cellular processes in order to produce more of the required protein or antibody.
The goal is to manipulate and replicate cells in the lab that produce proteins, antibodies, or other molecules at scale. It’s a process that begins with selecting a suitable cell type, followed by genetic modification to enable the cell to produce the desired molecule. The cells are then cultured and expanded, and the most productive ones are selected for further development and manufacturing.
Why Is Cell Line Development Important to CDMOs?
For CDMOs, cell line development is fundamental for several reasons.
A well-developed cell line ensures that the biological molecules produced are of high quality and are consistent from batch to batch. In addition, the ability to scale up production from a few cells to industrial quantities is crucial for meeting market demand, and this starts with a robust cell line.
Stable and high-yielding cell lines can significantly reduce the time it takes to move a drug from the development phase to commercial production, and optimized cell lines can produce higher yields of the desired molecule, reducing the overall cost of production. For Samsung Biologics, early assessment of a cell line is crucial for this optimization.
“[Cell line development] usually takes place under the cloud of competing entities racing to be first to market,” Seahee Kim and Daniel Buckley, scientists with Samsung Biologics, wrote in a recent white paper.
“Additionally, later development steps, some of which may be contractually obligated between a biopharma sponsor and its vendor partners, often are scheduled based on a fast, proficient CLD process. While it’s important to accelerate the overall product development timeline, CLD should prioritize early-stage assessment as a means of expediting development, rather than simply trying to complete the process quickly.”
Samsung Biologics’ Development Strategy
Samsung Biologics has capitalized on its expertise in cell line development to secure a competitive edge. The company has focused on the speed of constructing new facilities, but it has also emphasized the speed and quality of its biomanufacturing processes. This then has resulted in an influx of projects, listing over 230 regulatory approvals.
Monoclonal antibodies, which require highly specialized cell lines for their production, have become increasingly important in the treatment of various diseases, and Samsung Biologics specializes in the production of these antibodies. The company’s focus on cell lines for monoclonal antibodies aligns with broader pharmaceutical industry trends toward personalized medicine and next-generation therapies.
“Efforts to pioneer therapies for incurable diseases, the expiration of branded drugs, and the emergence of new afflictions are factors driving growing demand for CLD,” write Kim and Buckley.
Samsung Biologics’ emphasis on this area of increasing demand has had clear financial and strategic benefits. The company has seen consistent revenue growth, largely attributed to its strategic collaborations with top pharmaceutical companies. In 2023 alone it has signed deals with Pfizer, Bristol Myers Squibb, and other global pharma companies, and its sales backlog is now over 2 trillion South Korean won (about $1.5 billion).
With an investment of approximately 1.9 trillion Korean won in its upcoming Plant 5, Samsung Biologics is preparing for a future that promises even greater demand, particularly in monoclonal antibodies and biosimilars.
Cell line development is a critical component in the biopharmaceutical manufacturing process, and its importance to CDMOs like Samsung Biologics cannot be overstated. By leveraging its expertise in this area, Samsung Biologics has managed to secure a strong competitive position in a highly dynamic industry.