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Gains third approval for Plant 2 in 26 months
May 24, 2018
By: Kristin Brooks
Managing Editor, Contract Pharma
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...
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