April 20, 2024

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[THE INVESTOR] Samsung BioLogics, Korea’s biopharmaceutical contract development and manufacturing organization said on Oct. 1 that its third plant -- the world’s largest single bio manufacturing plant -- has commenced operations following validation.

The manufacturing facility with a capacity of 180,000 liters has completed self-validation in the past 10 months to undergo a test-run period for two years. It will then seek approval for full-fledged commercial production. 

The Samsung unit said its third plant is ready for current Good Manufacturing Practice, a pharma quality control regulation enforced by the US Food and Drug Administration.

“This means that Samsung BioLogics has become the largest bio manufacturing CMO in the world … we will continue to go forward to change the paradigm of biopharma industry with our manufacturing competitiveness,” CEO Kim Tae-han said in a statement.

The company invested some US$740 million for the new production site in Songdo, Incheon, where its first and second plants, which have 30,000 liters and 152,000 liters of capacity, respectively, are located.

Meanwhile, Samsung BioLogics said it has secured CDMO contracts with 24 companies for 33 products and received 19 global manufacturing approvals as of the end-September.

By Park Han-na (hnpark@heraldcorp.com)