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. T...