World’s Largest Biologics Plant Gets EMA Nod

European agency licenses Samsung BioLogics facility.

Touted as the world’s largest bioproduction plant, Samsung BioLogics announced the new facility, the second of its scale located in Incheon, received its first EU regulatory approval to produce monoclonal antibodies.

This second facility, approved last October by U.S. regulators, is now able to manufacture biopharmaceutical APIs for European clients and adds 152,000 liters of capacity in addition to its primary plant (which fields some 30,000 liters of capacity), according to the company.

On FDA approval, TH Kim, CEO of Samsung BioLogics remarked "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. We continue to be dedicated to exceed the strictest of the quality standards and our customers' expectations."

According to the company, it is pursuing the rapidly growing global biopharmaceutical market via its manufacturing strategy, one that will rely on scale and “world-class plant design and operation technology that maximizes production efficiency and ensures highest quality product for the patients.” Samsung has invested $740 million in a third plant scheduled to be operational in 2018.

 

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