August 16, 2018

Samsung BioLogics’ 2nd plant gets FDA approval

PUBLISHED : October 12, 2017 - 16:34

UPDATED : October 12, 2017 - 16:35

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[THE INVESTOR] Samsung BioLogics, the contract drug manufacturing arm of Samsung Group, said Oct. 11 it has been licensed by the US Food and Drug Administration for the first monoclonal antibody drug substance at its second facility, the world’s largest single plant.

With the first license of its second plant, located in Incheon, from the US regulator, Samsung BioLogics is now able to manufacture commercial Biologics Drug Substance there in addition to its first plant which has 30,000 liters of capacity.

Compared to its first plant which took 25 months to get FDA approval, approval for the second plant came in just 19 months since its Good Manufacturing Practices was ready in 2016.

The second plant with 152,000 liters of capacity is five times bigger than the first plant but Samsung saved six months to receive approval.

“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,” Samsung BioLogics CEO Kim Tae-han said.

The company said it has improved production efficiency by installing 10 bioreactors, breaking industry stereotypes of installing and operating only four or six bioreactors at a single bio-manufacturing plant.

Currently, the construction of Samsung BioLogics’ third plant with a bioreactor capacity of 180,000 liters is underway. The firm expects the construction to be completed by the fourth quarter of 2017.

Once the third plant is operational in 2018, Samsung BioLogics is expected to have the world’s largest capacity for a biologics contract manufacturing organization, with a total production capacity of 362,000 liters.

By Park Han-na (

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