Under the agreement, contract manufacturing organisation (CMO) Rentschler Fill Solutions (RFS) will manage the aseptic fill/finish production of Ultragenyx’s Mepsevvi for US commercial supply.
Mepsevvi (vestronidase alfa) is a recombinant form of the human enzyme beta-glucuronidase, indicated to treat patients with a rare genetic disorder called mucopolysaccharidosis VII.
The product was developed in collaboration with contract development and manufacturing organisation (CDMO) Rentschler Biopharma, which will continue to make the drug substance at its facility in Laupheim, Germany.
According to a RFS spokesperson, “the fill and finish activities are currently being transferred to RFS for commercial production.”
“RFS and RB have a strategic collaboration to enable project transfers such as this to happen smoothly and seamlessly,” she added.
The deal follows on from a strategic partnership between RFS and RB – formerly Rentschler Biotechnologie – signed in June last year, to offer clients a simpler solution for aseptic fill/finish solutions.
Under the agreement, “the client will have one contact person, the strategic agreement offers a one-stop-solution,” a Rentschler Biotechnologie spokesperson told us at the time.
While both firms are owned by the Rentschler families, the companies are unique entities.