South Korean drug manufacturer Samsung BioLogics reported on Wednesday the receipt of the US Food and Drug Administration's license to manufacture its third monoclonal antibody Drug Substance in its second plant, the world's largest single plant.
Following the US FDA's approval, the company has acquired the rights to manufacture three commercial Biologics Drug Substances at its second plant in just 26 months since GMP ready.
Both Plant 1 and Plant 2 are now compliant with global GMP standards upon receiving 14 global regulatory agency's approvals including FDA, EMA and PMDA. It has won the CMO Leadership Award presented by Life Science Leader in all six core categories for two consecutive years, added the company.
In conjunction, the company 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.
Additionally, the company received initial manufacturing approval for plant 2 six months faster than Plant 1, although Plant 2 is five times larger and ten times more complicated than plant 1.
From June 4-7 2018, the company will be exhibiting in the BIO International 2018 Conference in Boston for the eight consecutive year to pursue additional contracts.
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