Samsung BioLogics said Thursday that its second factory received manufacturing approval from the U.S. Food and Drug Administration (FDA).
The factory has a floor space of 81,945 square meters to become the world’s first biopharmaceutical factory to install 10 incubators, compared with the average of four to six incubators established and is expected to improve production efficiency. The approval was also granted after 19 months, six months earlier than that given to the company’s first factory.
Samsung BioLogics 삼성바이오로직스 developed an original design technology and adopted cutting-edge technology such as 3D modeling applied to semiconductor factory construction. Even though the complexity of the plant increased 10-fold, the factory’s design with efficient management in mind and accumulated quality management capability led to a global manufacturing approval in a short period, it said.
For biopharmaceuticals that rely on bringing their product to the market faster than their competitors, it is essential to obtain global manufacturing approval in a short time.
Recently, there have been cases with companies failing to produce pharmaceuticals on time after failing to receive production approval even after they completed developing their new drugs, increasing the importance of biopharmaceutical manufacturing competitiveness. In the case of CMO companies, global manufacturing approval is recognized as the company's quality control capabilities, the company added.
“Samsung BioLogics has opened a new chapter in the CMO market by building a world-class factory with the most competitive design and quality management, and did so faster than anyone else,” CEO Kim Tae-han 김태한 said. "We will continue to expand the CMO market by changing the paradigm of the biopharmaceutical manufacturing based on such competitiveness."
The company also plans to finish mechanical completion on its third factory by the end of this year. The factory will be larger than the previous two plants and will have increased production flexibility to enable the production of medium- to large-sized biopharmaceuticals.