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Samsung BioLogics, a contract manufacturer of biologic drugs under South Korea’s Samsung Group, said Thursday that its second production plant in Songdo had been approved for commercial production by the US Food and Drug Administration.
With the US FDA license, Samsung’s second plant equipped with 152,000 liters of production capacity is now able to commercially manufacture its first monoclonal antibody biologic drug substance for sale to the US.
With the US FDA license, Samsung’s second plant equipped with 152,000 liters of production capacity is now able to commercially manufacture its first monoclonal antibody biologic drug substance for sale to the US.
Adding to the first plant’s 30,000-liter capacity, Samsung can now commercially produce 182,000 liters of monoclonal antibody drug substances.
According to Samsung BioLogics, the US FDA’s license for the second plant came just 19 months after its Good Manufacturing Practices were ready in 2016.
“We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a GMP-certified manufacturing facility to provide high-quality products to our clients,” said Samsung BioLogics CEO Kim Tae-han.
By Sohn Ji-young (jys@heraldcorp.com)
