US FDA approves production at Samsung Biologics 152,000L plant

By Dan Stanton contact

- Last updated on GMT

The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.

Samsung Biologics’ second facility at its site in Incheon, South Korea was commissioned in 2013​ and received GMP accreditation last year.

And this week the contract development and manufacturing organisation (CDMO) announced it has received its first approval at the site for the manufacture of a monoclonal antibody drug substance by the US Food and Drug Administration (FDA).

Samsung Biologics would not provide further details of the drug or the scale of production when asked due to client confidentiality.

The manufacturer has a number of Big Biopharma clients on its books, including Bristol-Myers Squibb for which it makes Yervoy (ipilimumab)​ which is used to treat late-stage melanoma. The firm also has contracts with Roche​ and Samsung Bioepis.

Samsung Biologics has a 91% stake in Samsung Bioepis and Benepali – a biosimilar version of Amgen’s Enbrel owned by Samsung Bioepis – was named as the CMO’s ‘main’ product when it launched an IPO in August 2016​.

Last year, Biopharma-Reporter visited the facility which houses five times more bioreactor capacity than Samsung Biologics’ first facility housing 150,000L in ten stainless steel vessels supplied by Swiss firm Bioengineering AG, plus 2,000L of single-use capacity.

But while the facility is the largest single biomanufacturing facility in the world in terms of bioreactor capacity, it is soon to be topped by a third plant under construction at the site.

The $740m facility is expected to be completed by the end of the year, adding a further 180,000L of capacity. Once operational, Samsung Biologics will offer a total of 362,000L mammalian cell culture capacity.

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