Samsung BioLogics’ Third Manufacturing Facility, Songdo, South Korea


Samsung expects to be the world leader in biopharmaceutical contract manufacturing with the establishment of a new facility.

Samsung BioLogics, a leader in manufacturing biopharmaceutical products, broke ground for the construction of its third plant in Songdo, South Korea, on 21 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 company will invest KRW850bn ($721m) to build the world's biggest biopharmaceutical manufacturing facility in Songdo.

Construction on the facility is expected to be completed by 2017 and operations are scheduled to start in the fourth quarter of 2018 after receiving validation.

The establishment and operation of the new plant is expected to make the Samsung Group the world's biggest biologics contract manufacturing operator (CMO).

Location

The facility is being built in the Incheon Free Economic Zone (IFEZ), which comprises three regions namely Songdo, Cheongna, and the island of Yeongjong. The country's west coast originates at IFEZ and serves as a gateway to Seoul and a metropolitan area of central Korea.

Samsung BioLogics' manufacturing plant details

The new plant is designed to have an annual production capacity of approximately 180,000l, which will increase Samsung BioLogics' total production capacity to 360,000l a year when fully operational.

Annual sales and operating profits are expected to reach KRW2tn and KWR1tn respectively after full completion of the plant.

The new facility will supply biopharmaceutical products to meet growing manufacturing demands from global pharmaceutical companies. It will operate throughout the year and offer services to clients, including small-scale batches for clinical trials to supplying large-scale batches 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 wide range of solutions in biologics development and manufacturing.

Samsung BioLogics' bopharmaceutical portfolio

Samsung BioLogics is a contract manufacturing operator that produces biopharmaceutical products for established brands such as Bristol-Myers Squibb and Roche. It was established 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 plants in the Incheon zone. The first plant received production approval from the US Food and Drug Administration (FDA), while the second plant is expected to begin operations in early 2016.

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.

Facilities at existing plants

"Construction on the facility is expected to be completed by 2017 and operations are scheduled to start in the fourth quarter of 2018 after receiving validation."

Samsung's first plant accommodates six stainless steel bioreactors with an upstream capacity of 5,000l each and a total capacity of 30,000l. It is designed and built to carry rapid high protein production.

It contains suites for upstream, downstream, fill and finish units, and also has an administration building, as well as a warehouse including long-term cold storage capacity.

The second plant contains ten bioreactors with an upstream capacity of 15,000l each and a total capacity of 150,000l.

Services such as cell line generation, process and analytical method development and analytical services are offered at Samsung's facilities.

Other services include clinical and commercial bulk cGMP manufacturing of drug substances and drug products with quality assurance, quality control, regulatory compliance standards and support for customers.