FDA OKs Third mAb To Be Manufactured at Samsung BioLogics’ New PlantBy
The US Food and Drug Administration (FDA) has licensed a third monoclonal antibody drug substance to be manufactured at Samsung BioLogics’ biomanufacturing facility in Incheon, South Korea.
With this approval, the FDA has now approved manufacturing for three separate commercial biologic drug substances at the plant since the plant has become GMP ready in 2016. The plant has ten 15,000-liter bioreactors.
Source: Samsung BioLogics