Rentschler Fill Solutions, an Austria-based CMO and expert in aseptic fill and finish services, has announced a collaboration with Ultragenyx Pharmaceutical for drug product production of the injectable MepseviiTM (vestronidase alfa). MepseviiTM is a recombinant form of the human enzyme beta-glucuronidase, to treat patients with mucopolysaccharidosis (MPS) VII, a rare genetic disorder.
“Identifying a reliable and proactive drug product CMO partner for MepseviiTM was critical for Ultragenyx,” explained Dennis Huang, chief technical operations officer for California-based Ultragenyx.
“MepseviiTM 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," he added.
MepseviiTM was developed by US-based Ultragenyx in close collaboration with the biopharmaceutical CDMO Rentschler Biopharma SE in Laupheim, Germany, and was approved by the US FDA in November 2017.
Ultragenyx has applied for European marketing approval of MepseviiTM and the application is currently under review.
Fill and finish activities for the drug product will be transferred from Rentschler Biopharma SE to Austria-based Rentschler Fill Solutions GmbH, the new centre of excellence, featuring comprehensive services for the aseptic filling and freeze-drying of drug products.
Reinhold Elsaesser, one of the two managing directors of Rentschler Fill Solutions, commented: “We are delighted to be working with Ultragenyx at our facility in Austria, the cutting-edge centre of excellence for fill and finish solutions. The US is a key market for us. We are pleased that this collaboration provides the opportunity for us to demonstrate our facility’s US FDA compliance."
Elsaesser said the company will be closely collaborating with 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," he added.
Rentschler Biopharma SE will continue to manufacture the drug substance. Ultragenyx benefits from the advantages of the strategic partnership between Rentschler Fill Solutions GmbH and Rentschler Biopharma SE.
“For many years, Rentschler Biopharma has been a trusted partner of Ultragenyx in the development of MepseviiTM,” Dr Frank Mathias, CEO of Rentschler Biopharma SE, said. “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.”
Rentschler Fill Solutions offers its clients fill and finish services on both a clinical and commercial scale. Through the strategic partnership of Rentschler Fill Solutions, Rentschler Biopharma and Leukocare clients also benefit from one-stop solutions from gene to vial and clinic to market.
Rentschler Fill Solutions, together with Rentschler Biopharma and Leukocare, will present their end-to-end service offerings during the BIO International Convention, taking place June 4-7 in Boston, MA, USA, at booth 1155.