Samsung BioLogics granted FDA approval for its first monoclonal antibody Drug Substance

Samsung BioLogics has been granted approval by the US Food and Drug Administration (FDA) for the first monoclonal antibody Drug Substance at its second plant, which is also the world’s largest single plant. With this license, Samsung BioLogics can now manufacture commercial Biologics Drug Substance at its second plant other than its first plant, which has 30,000 litres capacity.

Samsung BioLogics is now able to manufacture commercial Biologics Drug Substance at its second plant.

The second plant is 5 times bigger and ten times more complicated than its first plant. Evenmore, with 152,000 litres capacity, the second plant is one and a half times larger than a standard world-cup stadium.

Samsung BioLogics has improved production efficiency through a world-first installation of ten bioreactors, 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 utilising its world-class plant design and operation technology that maximises production efficiency and ensures the highest quality products for patients.

It has also invested US$ 740mn in a third plant, with a bioreactor capacity of 180,000 litres. Construction is expected to be completed by the 4th quarter of 2017.

The third plant will be constructed with the most advanced technologies, including 3D modelling. Once this 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 litres.

Totally, Samsung BioLogics has a production capacity of 182,000 litres through its first plant with 30,000 litres' production capacity and second plant with 152,000 litres' combined. Its first plant started full commercial operations in November 2015, and the second one came into operations in February 2016.