FDA Licenses Second Samsung BioLogics Facility

Samsung BioLogics announced on Oct. 11, 2017 the company’s Songdo Plant 2 has been licensed by FDA for monoclonal antibody drug-substance production. The company reports that it has nine approvals from FDA, the European Medicines Agency, and the Pharmaceutical and Medical Devices Agency.

The 152,000-L facility joins the Songdo Plant 1, which has a capacity of 30,000 L. A third facility, with a capacity of 180,000 L, is scheduled for completion in the fourth quarter of 2018.

The company reports that it increased productivity and efficiency for Plant 2 compared to Plant 1; the facility was engineered for 10 culture mediums and one refining line; the first plant has six culture mediums and one refining line.

“We are eager to maintain and further improve our biopharmaceutical quality systems and manufacturing process in a GMP-certified manufacturing facility to provide high-quality products to our clients,” said TH Kim, CEO of Samsung BioLogics in a press statement. “We continue to be dedicated to exceeding the strictest of the quality standards and our customers’ expectations.”

Source: Samsung BioLogics