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.