Biopharmaceutical manufacturing plant
Samsung BioLogics opened its third biologics manufacturing plant in Songdo, South Korea, in October 2018. The plant made Samsung Group one of the world’s largest biologics contract manufacturing operators (CMO) in the world.
Construction began with the groundbreaking ceremony held in December 2015. The event was attended by Samsung Electronics’ vice-chairman Jay Y Lee and Samsung BioLogics’ president Dr TH Kim, as well as more than 500 attendees. The facility was completed in November 2017.
The company invested KRW850bn ($721m) to build the biopharmaceutical manufacturing facility.
In February 2018, Samsung BioLogics received its first manufacturing contract worth $148m for the plant.
Built in Incheon Free Economic Zone (IFEZ), the facilitiy comprises the Songdo and Cheongna regions, as well as Yeongjong Island. The country’s west coast originates at IFEZ and serves as a gateway to Seoul and a metropolitan area of central Korea.
Designed to deliver an annual production capacity of approximately 180,000l, the plant increases Samsung BioLogics’ total production capacity to 360,000l a year.
The facility supplies biopharmaceutical products to meet growing manufacturing demands from global pharmaceutical companies. It operates throughout the year and offers services to clients, including small-scale batches for clinical trials to supplying large-scale shipments for commercial production.
The number of pharmaceutical products the company will produce is estimated to be 350 by 2020.
Samsung BioLogics has two large-scale facilities located in Incheon, which offer a range of solutions in biologics development and manufacturing.
Samsung BioLogics is a contract manufacturing operator that produces biopharmaceutical products for established brands such as Bristol-Myers Squibb and Roche, founded by Samsung Electronics, Samsung Everland, Samsung C&T and Quintiles Transnational.
The company entered a ten-year contract with Bristol-Myers Squibb for manufacturing a commercial antibody cancer drug at its new plant.
Samsung BioLogics already has two biopharmaceutical plants in the Incheon zone. The first plant received production approval from the US Food and Drug Administration (FDA) for the manufacture of biologics drug substances in November 2015 and European Medicines Agency (EMA) in July 2016 monoclonal antibody drug substances, while the second plant received FDA and EMA approvals for the first monoclonal antibody drug substance in October 2017 and December 2017, respectively.
Samsung BioLogics aims to increase the global pharmaceutical capability through its fully integrated production facility that offers process development, drug substance manufacturing and fill and finish services at a single location.
Samsung’s first plant accommodates six stainless steel bioreactors with an upstream capacity of 5,000l each and a total capacity of 30,000l, designed and built to carry rapid high protein production.
It contains suites for upstream, downstream, fill and finish units, as well as has an administration building and a warehouse with long-term cold storage capacity.
The second biopharmaceutical manufacturing plant contains ten bioreactors with an upstream capacity of 15,000l each and a total capacity of 150,000l.
Samsung offers services such as cell line generation, process and analytical method development and analytical services at its facilities.
Other services include clinical and commercial bulk current good manufacturing practice (cGMP) manufacturing of drug substances and drug products with quality assurance, quality control, regulatory compliance standards and support for customers.
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