Samsung BioLogics’ third monoclonal antibody drug substance has been licensed by the U.S. FDA for its second plant. The company has now been approved by the FDA for the manufacture of three commercial Biologics Drug Substances at its second plant in just 26 months since being GMP ready in 2016. 
 
Samsung BioLogics has improved production efficiency with the installation of ten 15,000L bioreactors in a single bio-manufacturing plant. Plant 2 is five times larger and more complicated than Plant 1 and received initial manufacturing approval 6 months faster.

Plant 1 and Plant 2 are compliant with global GMP standards having received 14 global regulatory agency’s approvals including FDA, EMA, and PMDA. 
 
TH Kim, chief executive officer and president of Samsung BioLogics, said, “There has been some cases recently where CMO’s failure of receiving approval affects the clients’ drug marketing schedule. Samsung BioLogics has once again demonstrated that it possesses world class Quality with Data Integrity which is critical to get global approvals. 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. We will continue to do our best to continuously innovate ourselves so that clients and patients can receive high quality medical products in a timely manner”