Samsung BioLogics has been licensed by the European Medicines Agency (EMA) for the first monoclonal antibody drug substance at its second plant, which has 150,000-liter capacity. This approval comes only two months after the U.S. FDA granted its approval for the plant. Samsung BioLogics carried out FDA and EMA inpections simultaneously last July.

Plant No. 2 was constructed with Samsung’s design and construction method, which it says enabled it to install 10 bioreactors at the single plant. The plant is five times larger than its industry average 30,000-liter capacity plant No. 1. The company also said inspections were far more complicated because the FDA and EMA inspection period overlapped.

According to the company, it has set the record for the shortest time to get an approval in the industry. Plant No. 1 achieved FDA approval in 25 months after it started operation. The says it broke its own world record with plant No. 2 achieving first approval in 19 months, 6 months faster than plant No. 1.

So far Samsung BioLogics has received 11 manufacturing approvals from the U.S., Europe, and Japan, which are the top three global bio markets, in six years since its establishment. The company has won 15 product manufacturing orders from 10 pharmaceutical companies including BMS and Roche.

At the same time, Samsung’s third plant, which was completed last month, has 180,000-liter capacity. With the addition of this capacity, Samsung BioLogics will carry a total production capacity of 362,000-liters.

“Samsung BioLogics has proved once again that it possesses world class capability in quality as well as production scale,” said Tae Han Kim, chief executive officer and president, Samsung BioLogics. “We will continue to do our best to continuously innovate ourselves so that clients and patients can received medical products in a timely manner.”