[THE INVESTOR] Samsung BioLogics said on May 24 that the production of a third monoclonal antibody drug substance has been approved by the US Food and Drug Administration for its second plant.

With the green light, Samsung BioLogics has now got approval from the FDA for manufacturing three commercial biologics drug substances at its 152,000 liter-plant since 2016. Contract drug manufacturers are required to get approval from the FDA for their production site to produce pharmaceutical products, developed by their client drug makers, for sale in the US.

“Samsung BioLogics has once again demonstrated that it possesses world class quality with data integrity which is critical to get global approval. Samsung BioLogics has been striving to establish a system to completely prevent even tiny data errors that may occur during the whole production process of biopharmaceuticals from the establishment of the company and to set it up as a corporate culture,” Samsung BioLogics CEO Kim Tae-han said in a statement. 

According to the company, it has improved production efficiency through the installation of 10 15,000 liter bioreactors, breaking industry norms of installing and operating between four or six bioreactors in a single bio-manufacturing plant. 

Samsung BioLogics has demonstrated that both the first and second plant, located in Incheon, are compliant with global good manufacturing practice standards through receiving 14 global regulatory agency’s approvals in the US, EU and Japan.

“Although the second plant is five times larger and 10 times more complicated, Samsung BioLogics received initial manufacturing approval six months faster than the first plant. This shortened time in construction and period of approval allows our clients to quickly supply their products to the market,” the company said.

Meanwhile, Samsung BioLogics is expected to deliver its second round of defense before authorities on May 25 after financial regulators made a tentative decision that the firm had breached accounting rules in order to inflate its profit in 2015. The final ruling on the fraud allegations will come on June 6.

By Park Han-na (hnpark@heraldcorp.com)