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Samsung BioLogics gets go-ahead for new plant

Oct 13,2017
Samsung BioLogics has obtained manufacturing approval from the U.S. Food and Drug Administration for its second plant in Songdo, Incheon.

It took 19 months for the biopharmaceutical arm of Samsung to get the green light from the U.S. authority, six months shorter than the process took for the company’s first plant in the biopharmaceutical hub town. Samsung BioLogics announced the manufacturing approval on Thursday.

The company manufactures biopharmaceutical products for global pharmaceutical leaders such as Roche Holding and Bristol-Myers Squibb.

The second plant spans 81,945 square meters (20.2 acres), about 1.5 times the size of Sangam World Cup Stadium in western Seoul, and houses 10 cell culture media, the largest number in the world. A single factory normally runs four to six media, the company claims, and the larger the number of media, the more enhanced production efficiency becomes.

“We are rewriting the history of Korea’s contract manufacturing organization market by constructing and managing factories faster than others, backed up by distinguished design and quality control competitiveness,” said Samsung BioLogics CEO Kim Tae-han, vowing to change the paradigm for biopharmaceutical sales.

Since obtaining approval from the U.S. FDA for its first plant in November 2015, Samsung BioLogics has earned manufacturing approval nine times from multiple organizations for multiple products.

The Samsung subsidiary is slated to complete its third plant with a 180,000-liter (47,550-gallon) capacity by the end of this year.


BY SEO JI-EUN [seo.jieun@joongang.co.kr]