Samsung BioLogics has been licensed by the Europe’s EMA (European Medicines Agency) for the first monoclonal antibody Drug Substance at its second plant.
This approval is only two months after the FDA approval for the plant No. 2. Samsung BioLogics carried out FDA and EMA inspections together in last July.
Plant No. 2 was constructed with Samsung BioLogics’ unique design and construction method, which enables the company to install 10 bioreactors at a single plant. The new plant is five times larger and over 10 times more complicated than the industry average 30K capacity than the first plant. The EMA inspection overlapped with FDA inspection.
Samsung BioLogics has received 11 manufacturing approvals from US, Europe, and Japan, which are the top three global bio markets. The company has won 15 products manufacturing orders from 10 pharmaceutical companies including BMS and Roche.
“Samsung BioLogics has proved once again that it possesses world class capability in quality as well as the production scales.” Tae Han Kim, CEO and President of Samsung BioLogics, said. “We will continue to do our best to continuously innovate ourselves so that clients and patients can received medical products in a timely manner”.