DSM selected as second manufacturer of Factor IX mAb
The Dutch not-for-profit firm Sanquin Blood Supply Foundation has the marketing authorisation for Nonafact, a drug that treats and prevents bleeding in patients with haemophilia B and contains the active ingredient human coagulation factor IX.
The monoclonal antibody in NoNafact is used for the recovery and purification of factor IX, Sanquin spokesperson Merlijn van Hasselt told Biopharma-Reporter.com.
“Sanquin itself is the first supplier of the monoclonal antibodies,” he said, but this contract with fellow Netherlands-headquartered company DSM will secure a second manufacturer to “ensure a guaranteed availability of this medicine in anticipation of a growing market.”
Financial details were not divulged but van Hasselt told us the firm anticipated a long-term relationship with the contract manufacturer.
“DSM has a proven track record in the manufacturing of monoclonal antibodies for medicinal use and for the use as auxiliary material,” he said, and “the production capacity of this antibody will be doubled through this agreement.”
The iX Factor
“The antibody binds highly specific to Factor IX, which is present in human plasma,” van Hasselt explained, with the antibody subsequently bound to a resin. “This resin is packed into a column that is used in the purification process of Nonafact.”
He continued: “With the purification using this particular column (intrinsically) a Factor IX concentrate of very high purity is obtained,” in a principle known as 'Monoclonal antibody purification.'
“The Factor IX concentrate is then processed into Nonafact(r), a medicine to help treat patients suffering from hemophilia B.”