05.30.18
Rentschler Fill Solutions GmbH entered a collaboration with Ultragenyx Pharmaceutical, Inc. for the drug product production of the injectable Mepsevii (vestronidase alfa), a recombinant form of the human enzyme beta-glucuronidase, to treat patients with mucopolysaccharidosis (MPS) VII, a rare genetic disorder.
Mepsevii was developed by U.S.-based Ultragenyx in collaboration with Rentschler Biopharma SE in Germany, and was approved by the U.S. FDA in November 2017. Ultragenyx has also applied for European marketing approval of Mepsevii. Fill and finish activities for the drug product will be transferred from Rentschler Biopharma SE to Austria-based Rentschler Fill Solutions GmbH, the new center of excellence, offering comprehensive services for the aseptic filling and freeze drying of drug products. Rentschler Biopharma SE will continue to manufacture the drug substance.
“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.”
Reinhold Elsaesser, a managing director of Rentschler Fill Solutions, said, “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 U.S. is a key market for us and we are pleased that this collaboration provides the opportunity for us to demonstrate our facility’s U.S. FDA compliance. 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.”
Mepsevii was developed by U.S.-based Ultragenyx in collaboration with Rentschler Biopharma SE in Germany, and was approved by the U.S. FDA in November 2017. Ultragenyx has also applied for European marketing approval of Mepsevii. Fill and finish activities for the drug product will be transferred from Rentschler Biopharma SE to Austria-based Rentschler Fill Solutions GmbH, the new center of excellence, offering comprehensive services for the aseptic filling and freeze drying of drug products. Rentschler Biopharma SE will continue to manufacture the drug substance.
“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.”
Reinhold Elsaesser, a managing director of Rentschler Fill Solutions, said, “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 U.S. is a key market for us and we are pleased that this collaboration provides the opportunity for us to demonstrate our facility’s U.S. FDA compliance. 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.”