Samsung BioLogics said Thursday that it has received approval for a drug substance manufacturing process at its second plant, from the U.S. Food and Drug Administration (FDA).
With the recent approval, the company’s second factory now holds three biologic drug substance manufacturing processes approved by the FDA.
Samsung BioLogics second factory with the floor space of 81,945 square meters is the world’s first biopharmaceutical plant to install 10 bioreactors, compared with the average of four to six bioreactors established, which have significantly improved production efficiency.
In biopharmaceutical industry where it is essential for companies to bring their drug faster into the market than their competitors, it is vital to obtain global manufacturing approval in a short period. The company has been able to reduce the certification winning period significantly so that its client companies can supply their drugs in a timely and stable manner.
The company has also demonstrated that both of its plants comply with global GMP standards by receiving 14 drug manufacturing procedure approvals from the FDA, European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PDMA).
Thanks to the competitiveness, Samsung BioLogics has won the CMO Leadership Award presented by Life Science Leader in all six core categories -- quality, competence, reliability, expertise, compatibility, and service -- for two consecutive years.
“The most important aspect in the biopharmaceutical industry is to establish a system and corporate culture that prevents any data errors that may occur during the production process, especially regarding data integrity,” Samsung BioLogics CEO Kim Tae-han said. “We will continue to do our utmost to ensure that patients and our customers receive their medication on time.”
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