Contract manufacturing organisation (CMO) and aseptic fill and finish services expert, Rentschler Fill Solutions, has announced its collaboration with Ultragenyx Pharmaceutical for the production of the drug product of the injectable Mepsevii (vestronidase alfa).
collaboration
Mepsevii is a recombinant form of the human enzyme beta-glucuronidase and is used in the treatment of mucopolysaccharidosis (MPS) VII, a rare genetic disorder. It was developed by US-based Ultragenyx in close collaboration with the biopharmaceutical CDMO Rentschler Biopharma in Laupheim, Germany, and was approved by the US FDA in November 2017. European marketing approval has been applied for by Ultragenyx but this is currently under review.
“Identifying a reliable and proactive drug product CMO partner for Mepsevii was critical for Ultragenyx,” said Dennis Huang, chief technical operations officer for Ultragenyx. “Mepsevii is our first commercial product and treats an ultra-rare disease. Rentschler Fill Solutions understood our specific needs and shared our vision of serving patients with MPS VII who previously had an important unmet medical need. We look forward to working with Rentschler Fill Solutions and Rentschler Biopharma to smoothly transition the fill and finish activities.”
“We are delighted to be working with Ultragenyx at our facility in Austria, the cutting-edge center of excellence for fill and finish solutions. The US is a key market for us and we are pleased that this collaboration provides the opportunity for us to demonstrate our facility’s US FDA compliance,” revealed Reinhold Elsaesser, one of the two managing directors of Rentschler Fill Solutions. “We will be closely collaborating with our partner Rentschler Biopharma throughout the project, from drug substance delivery to regulatory affairs and drug product supply. Our processes are aligned to ultimately deliver a high-quality product for our joint client Ultragenyx.”
“For many years, Rentschler Biopharma has been a trusted partner of Ultragenyx in the development of Mepsevii,” explained Dr Frank Mathias, CEO of Rentschler Biopharma. “We welcome their decision to continue and broaden our joint success story together with Rentschler Fill Solutions. This project reaffirms our strategic partnership with Rentschler Fill Solutions, announced a year ago, as we are able to meet our clients’ needs not only as a solution provider for clinical trials but also for market supply in growing international markets.”