James Yoon, spokesman for Samsung, explained the layout of the Incheon facility to Biopharma-Reporter.com: “Currently we are running 30,000 [Liters] (6 bioreactors of 5000L) mammalian cell culture which started commercial operation in June 2013.”
Samsung also has more capacity to meet demands from other clients as, in addition to the first plant, the company is constructing a second facility that is expected to be complete by Q1 of 2015 and ready for GMP operation by Q2 of 2016, Yoon told us.
“The 2nd plant is 150,000L (10 bioreactors of 15,000L) which is five times bigger than the first plant,” and both plants are stainless steel plants, Yoon added. “Another 2,000L (2 bioreactors of 1,000L) clinical manufacturing plant will be ready for GMP operation in 2016,” which will be a combination of stainless steel bioreactors and single-use system for purification, Yoon explained.
The plant servicing B-MS, as well as the second plant, are “fully equipped with fill/finish plants including vial and lyo manufacturing and bonded warehouses to supply one stop service from process development, drug substance, drug product to storage service.”
The deal follows a similar deal cemented in July in which B-MS selected Samsung to manufacture its monoclonal antibody Yervoy, which is used to treat late-stage melanoma, at the same South Korean plant for the next 10 years.
B-MS spokesman Ken Dominski told us, “This agreement increases our biologic manufacturing capacity to help ensure sufficient, long-term supply of our commercial products and is intended to compliment capacity already in place.”
He also explained the supply chain process by which the biologics are manufactured: “We manufacture the bulk drug substance for our biologic medicines at our Syracuse, N.Y., and Devens, Mass., sites, and through other third party suppliers. These medicines are finished and packaged at our manufacturing facilities in Manati, Puerto Rico, and Anagni, Italy.”
Both Samsung and B-MS have inked a number of partnerships in the last few months, with Samsung establishing a strategic manufacturing alliance with Roche in October, while last month B-MS entered a drug discovery deal with Five Prime Therapeutics to focus on immuno-oncology treatments.
Samsung has more capacity for future customers as well, Yoon added, noting, “At the moment we are actively under discussion with qualified customers for their manufacturing requirements.”