FDA OKs Second Samsung BioLogics’ Biomanufacturing Facility in Korea

The US Food and Drug Administration (FDA) has licensed Samsung BioLogics’ biomanufacturing facility in Incheon, South Korea for monoclonal antibody drug substance production. Samsung BioLogics is a contract biologics manufacturer.

Samsung BioLogics has total production capacity of 182,000 liters through its first plant, which started full commercial operation in November 2015, and its second plant, which started operation in February 2016. Samsung BioLogics is now able to manufacture commercial biologics drug substances at the second plant in addition to its first plant, which has 30,000 liters of capacity. Samsung BioLogics’ second plant has 152,000 liters of capacity.

Samsung BioLogics is investing $740 million in a third plant in Incheon, South Korea with a bioreactor capacity of 180,000 liters and expects the construction to be completed by the fourth quarter of 2017. The company’s third plant, which includes 3D modeling, is expected to be operational in 2018, and gives Samsung BioLogics total production capacity of 362,000 liters.

Source: Samsung BioLogics


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