Samsung Biologics’ second facility at its site in Incheon, South Korea was commissioned in 2013 and received GMP accreditation last year.
And today 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 European Medicines Agency (EMA), following an inspection by the Agency in July.
Details of the drug and the scale of production were not disclosed.
The manufacturer has a number of major biopharma clients on its books, including Bristol-Myers Squibb for which it makes the late-stage melanoma treatment Yervoy (ipilimumab). 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 November 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 hybrid 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 at the site, the construction of which was recently completed.
Once validated, the $740m facility will add a further 180,000L of capacity giving Samsung Biologics a total of 362,000L mammalian cell culture capacity.