This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|December 13, 2017
EMA Approves mAb Production at Samsung BioLogics Facility
Author(s)Pharmaceutical Technology Editors
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.
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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
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.
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