Samsung Biologics biggest plant received FDA approval

| By | FDA, GMP Standards, Samsung

Samsung BioLogics announced 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.

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.

SOURCE: samsung biologics
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.