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Samsung BioLogics awarded first US FDA approval at the world's largest biologics drug substance plant.

M2 PHARMA-October 12, 2017-Samsung BioLogics awarded first US FDA approval at the world's largest biologics drug substance plant


Process development company Samsung BioLogics reported on Wednesday the receipt of license from the US FDA (Food and Drug Administration) for the first monoclonal antibody drug substance at its second plant.

Following the first US FDA license for its second plant, the company is now able to manufacture commercial Biologics Drug Substance at its new 152,000 litres of capacity site in addition to its first plant (30,000 litres of capacity).

The company has received the US FDA approval for its second plant, which is the world's largest single plant in 19 months since its GMP (Good Manufacturing Practices) was ready in 2016, compared to its first plant which took 25 months to get approval from US FDA. The second plant is five times bigger and ten times more complicated than its first plant. The size of its second plant is one and a half times larger than a standard world-cup stadium.

According to the company, it has improved production efficiency through the installation of ten bioreactors for the first time in the world, breaking industry stereotypes of installing and operating only four or six bioreactors on a single bio-manufacturing plant.

In conjunction, the company's proposed USD740m third plant with a bioreactor capacity of 180,000 litres will be the world's largest capacity for a biologics contract manufacturing organisation (CMO), with a total production capacity of 362,000 litres.

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Publication:M2 Pharma
Date:Oct 12, 2017
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