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Samsung: FDA and EMA approval

FDA and EMA approval for the world’s largest single biomanufacturing facility

Samsung: FDA and EMA approval

In October 2017 our customer Samsung Biologics in Incheon, South Korea, received its approval for the manufacture of a monoclonal antibody drug substance by the American FDA and European EMA. The facility completed in 2015 currently is the largest single biomanufacturing facility in the world in terms of bioreactor capacity and houses five times more bioreactor capacity than Samsung Biologics’ first facility. Both facilities were built by Bioengineering AG.

Read more to the FDA approval

Read more to the EMA approval

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