- 3rd approval for Plant 2 in just 26 months since GMP ready
- CEO TH Kim "Samsung BioLogics once again demonstrated its superior quality capability with data integrity"
INCHEON, South Korea, May 24, 2018 /PRNewswire/ -- 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, the world's largest single 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.
For the 2018 CMO Leadership Awards, more than 110 CMOs from around the world were evaluated on 23 performance metrics to determine winners in the six categories. Only CMO clients participate in the survey, which enhances the validity of the award.
TH Kim, CEO 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." Then he added that "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.
TH Kim also said "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"
Samsung BioLogics will be attending the BIO International 2018 Conference in Boston June 4-7, 2018, as an exhibitor for the 8th year in a row to pursue additional contracts.