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The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.
On Dec. 13, 2017, Samsung BioLogics announced that it received approval from the European Medicines Agency (EMA) for the production of a monoclonal antibody (mAb) drug substance at its second facility in Songdo, Incheon, South Korea. This marks the first mAb that will be produced at the 152,000-L bioproduction facility, according to the company.
Details regarding the drug and the scale of production were not released.
This approval follows the facility’s October 2017 FDA approval for mAb manufacturing. Both EMA and FDA inspections occurred in July 2016.
According to the company, the facility has 10 bioreactors and is five times larger than its first Songdo facility, which has a capacity of 30,000 L. Most recently, the company’s third Songdo facility was completed in November 2017 with a 180,000-L capacity, bringing total company production capacity to 362,000 L.
Source: Samsung BioLogics