Samsung BioLogics has been licensed by the U.S. FDA for the first monoclonal antibody drug substance for sale to the U.S. at its second plant. The company says the plant is the world’s largest single plant with 152,000-liter capacity.

With the first license of its second plant from the FDA, Samsung BioLogics is now able to manufacture commercial biologics drug substance at its second plant in addition to its first plant, which has 30,000-liter capacity. Currently, Samsung BioLogics has a total production capacity of 182,000 liters between its two plants.

Samsung BioLogics received approval for its second plant from FDA in just 19 months since it became GMP ready in 2016.
 
“We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a GMP-certified manufacturing facility to provide high-quality products to our clients,” said TH Kim, chief executive officer, Samsung BioLogics. “We continue to be dedicated to exceed the strictest of the quality standards and our customers’ expectations.”
 
Samsung BioLogics has invested $740 million in a third plant with a bioreactor capacity of 180,000-liter capacity and expects the construction to be completed by the 4th quarter of this year.

Once the third plant is operational in 2018, Samsung BioLogics is expected to have the world’s largest capacity for a biologics contract manufacturing organization (CMO), with a total production capacity of 362,000 liters.