Samsung, the South Korean company best known to Americans for televisions and other electronic equipment, is branching out to make biopharmaceuticals. In May, ground was broken for Samsung Biologics located in Incheon, South Korea; full-scale operation is expected to start by January 2013. The plant will be fully equipped with cutting-edge technologies, such as 30,000 liter mammalian cell culture bioreactors. When fully operational, the plant will employ 200–300 workers.
In addition to electronics manufacturing, Samsung has divisions involved in construction, shipbuilding, textiles, finance, and medical devices, among others. “We are known for high-quality manufacturing of complicated materials, and we can bring our talents and technical confidence to manufacturing biopharmaceuticals,” says Kyu-sung Lee, Ph.D., senior vice president at Samsung Biologics. Technologies that Samsung already excels at, such as hygienic piping, cleanrooms, HVAC, and quality control, are readily transferred to building and operating the biopharmaceutical facility.
The launch of the new biologics business builds on the company’s past achievements. Its customer-oriented business model will, it says, bring collaborative drug-development and high-quality, fast-turnaround contract manufacturing to partners. “We will prove that we can deliver the quality and service shown by Samsung in other areas like electronics,” says Dr. Lee.
Biosimilars
The plant will focus on contract manufacturing of biopharmaceuticals for customers. Samsung also has its own R&D pipeline of monoclonal antibody candidates to treat cancer, arthritis, and other illnesses. “We will manufacture our own biologics when they are far enough along,” explains Dr. Lee. The plant will operate under global GMP compliance, and products will be sold worldwide. “Having a plant in Asia makes it easier for clients to penetrate the Asian market.”
The facility is a multiproduct plant that meets the requirements of the U.S. FDA and the EMEA. The plant accommodates minimum change over time between production runs to meet clients’ targets. In addition to the production unit, the facility contains Samsung Biologics R&D center, an upstream suite, downstream suite, fill-and-finish suite, administrative offices, and a warehouse with long-term cold storage capacity.
Facility Capabilities
Samsung Biologics will focus on mammalian cell culture. Services range from protein target purification, process development, and aseptic fill and finish for any scale, from preclinical quantities to commercial production. “We designed the facility to meet our manufacturing conditions and issues,” noted Dr. Lee.
Cell-line development starts with DNA sequencing, clone screening and selection, and cell-line stability studies. Researchers at Samsung Biologics have extensive experience in working with many types of mammalian cell lines. The facility is custom designed for mammalian cell therapeutic monoclonal antibody production with maximum flexibility.
Core competencies in upstream development include selection and development of cell culture media on a flask scale; optimization using 1 to 5 liter bioreactors; and scaleup to 200 liters. Downstream process-development includes resin screening for chromatographic optimization and scale-down validation, and process characterization to improve a protein’s therapeutic attributes. The filling suite is modularly designed to meet future additional pre-filled syringe, liquid fill, and lyophilization units.
The quality assurance (QA) division functions independently of all other operations to insure high-quality products and services that meet legal requirements and comply with regulatory guidelines. The QA specialists oversee proper release and/or rejection of raw materials, intermediates, and packaging and labeling of materials. They also approve all specifications, standard operating procedures, and master batch records.
Chemists, immunologists, and microbiologists in the quality control (QC) department will insure that high-quality products are made in a controlled environment. The QC team will test all manufacturing processes at various points, including raw materials and samples in process and released, as well as water systems and clean steam and gas supplies. All quality analyses will be conducted under strict GMP standards.
“Even though we have no history of biomanufacturing, we hired seasoned executives from the United States who know about biomanufacturing, technology transfer, and validation and quality control,” says Dr. Lee.