– Licensed by US FDA regulatory for its second plant manufacture of Biologics Drug Substance for the first time
– Prove its global quality competitiveness such as biopharmaceutical quality and manufacturing systems with the world largest single plant with 152,000 liters of capacity in addition to its first plant
– Continue to prepare to receive more inspections for the Market Expansion
INCHEON, South Korea, Oct. 11, 2017 /PRNewswire/ — Samsung BioLogics announced today 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 (Good Manufacturing Practices) 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 aims to strengthen its presence in the rapidly growing global biopharmaceutical market by utilizing its world-class plant design and operation technology that maximizes production efficiency and ensures highest quality product for the patients.
Samsung BioLogics has invested USD 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.
About Samsung BioLogics
Samsung BioLogics is a world class full service provider of quality driven contract process development and cGMP manufacturing to the global biopharmaceutical industry. Established in April 2011, Samsung BioLogics will transform the global healthcare industry over the next decade, through our quality, technology and innovation. Our facilities are custom designed for monoclonal & recombinant production with maximum flexibility. Our end-to-end service includes cell line process and analytical method development, analytical services (characterization, comparability, IPC, lot release & stability), clinical and commercial bulk cGMP manufacturing of drug substance and drug product including Quality Assurance, and Quality Control. Samsung BioLogics is committed to meeting or exceeding worldwide regulatory compliance standards and support for our customers.
For additional information about the company, please visit http:/www.samsungbiologics.com/.
SOURCE Samsung BioLogics Co., Ltd.
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