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FDA Approves Samsung Biologics’ Second Plant

Contract manufacturer gets the ‘green light’ for commercial production at 152,000-liter plant

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Samsung BioLogics has been licensed by the U.S. FDA for the first monoclonal antibody drug substance for sale to the U.S. at its second plant. The company says the plant is the world’s largest single plant with 152,000-liter capacity. With the first license of its second plant from the FDA, Samsung BioLogics is now able to manufacture commercial biologics drug substance at its second plant in addition to its first plant, which has 30,000-liter capacity. Currently, Samsung BioLogics has a tota...

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