EMA approves production at Samsung Biologics 152,000L plant

By Staff Reporter

- Last updated on GMT

GettyImages/Golden_Brown
GettyImages/Golden_Brown

Related tags: Bristol-myers squibb, Samsung biologics

The world’s largest single bioproduction plant has received its first EU 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 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​​.

Capacity hike

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.

Related news

Show more

Related products

Microsampling in Early Phase Drug Development

Microsampling in Early Phase Drug Development

Altasciences | 10-May-2022 | Technical / White Paper

Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic...

Seasonal Vaccine Manufacturing

Seasonal Vaccine Manufacturing

Baxter BioPharma Solutions | 16-Feb-2022 | Technical / White Paper

The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...

Consideration and Options for Prefilled Syringes

Consideration and Options for Prefilled Syringes

Baxter BioPharma Solutions | 16-Feb-2022 | Technical / White Paper

Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...

Partner with Experts in Precision Medicine

Partner with Experts in Precision Medicine

CellCarta | 17-Jan-2022 | Product Brochure

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

Related suppliers