Samsung BioLogics announced today that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant.
With the approval, Samsung BioLogics has been approved by the FDA for the manufacture of three commercial Biologics Drug Substances at only its second plant in just 26 months since being GMP ready in 2016.
Samsung BioLogics has improved production efficiency through the installation of ten 15,000L bioreactors, a world's first, breaking industry stereotypes to install and operate only four or six bioreactors in a single bio-manufacturing plant.
Samsung BioLogics has demonstrated that both Plant 1 and Plant 2 are compliant with global GMP standards through receiving 14 global regulatory agency's approvals including FDA, EMA, and PMDA.
Although Plant 2 is 5 times larger and 10 times more complicated, Samsung BioLogics received initial manufacturing approval 6 months faster than Plant 1. This shortened time in construction and period of approval allows our clients to quickly supply their products to the market.
With its competitiveness, Samsung BioLogics has won the CMO Leadership Award presented by Life Science Leader in all six core categories for two consecutive years.
"There has been some cases recently where CMO's failure of receiving approval affects the clients' drug marketing schedule," TH Kim, CEO and President of Samsung BioLogics, said. "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.”