Samsung Biologics achieved FDA approval for its largest plant

| By | FDA, GMP Standards, Pharmaceutical Manufacturing, Samsung

Samsung BioLogics announced that on October 11, 2017, it has been licensed by the US FDA (Food and Drug Administration) for the first monoclonal antibody Drug Substance at its second plant, the world‘s largest single plant.

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 liters of capacity. Compared to its first plant which took 25 months to get approval from FDA, Samsung BioLogics received approval of its second plant from FDA in just 19 months since its GMP  was ready in 2016.

Samsung’s second plant with 152,000 liters of capacity is 5 times bigger and ten times more complicated than its first plant but Samsung saved 6 months to receive the first approval from the FDA. The size of its second plant is one and a half times larger than a standard world-cup stadium. Samsung BioLogics 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.

With a total of nine approvals now from FDA, EMA, and PMDA, Samsung has proved that all Samsung facilities are compliant with global GMP standards.

“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 TH Kim, CEO of Samsung BioLogics. “We continue to be dedicated to exceed the strictest of the quality standards and our customers’ expectations.”

Samsung BioLogics has invested $740 million in its third plant with a bioreactor capacity of 180,000 liters and expects the construction to be completed by the 4th quarter of this year.

Once the third plant, constructed with the most advanced technologies including 3D modeling, is operational in 2018, Samsung BioLogics is expected to have the world’s largest capacity for a biologics contract manufacturing organization (CMO), with a total production capacity of 362,000 liters.

Currently, Samsung BioLogics has the production capacity of 182,000 liters through its first plant with 30,000 liters of capacity, which started full commercial operation in November 2015, and second plant with 152,000 liters of capacity, which started operation in February 2016.

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