Rentschler Fill Solutions GmbH
Rentschler Fill Solutions and Ultragenyx start fill & finish collaboration for the US commercial supply of drug product Mepsevii
Rentschler Fill Solutions and Ultragenyx start fill & finish collaboration for the US commercial supply of drug product MepseviiTM – Collaboration provides Ultragenyx access to Rentschler Fill Solutions’ new center of excellence for the aseptic filling of biopharmaceuticals. – MepseviiTM, developed in collaboration with Rentschler Biopharma, is the first and only drug approved for the treatment of children and adults with mucopolysaccharidosis VII, a rare genetic disorder. Rankweil, Austria, May 30th, 2018 – Rentschler Fill Solutions GmbH, a CMO and expert for aseptic fill and finish services, today announced a collaboration with Ultragenyx Pharmaceutical, Inc. for the drug product production of the injectable MepseviiTM (vestronidase alfa), 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,” said Dennis Huang, Chief Technical Operations Officer for 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.” Reinhold Elsaesser, one of the two Managing Directors 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 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. 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.” 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, commented. “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. “Today’s news proves the high value that our services can provide our clients all along the biopharmaceutical value chain. Together with Rentschler Fill Solutions and Leukocare, renowned for best-in-class formulation development, we offer our clients end-to-end solutions, all from a single source,” Dr. Frank Mathias concluded. 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. About Rentschler Fill Solutions GmbH Contact: Rentschler Biopharma SE End of Media Release Issuer: Rentschler Fill Solutions GmbH Key word(s): Research/Technology
30.05.2018 Dissemination of a Press Release, transmitted by DGAP – a service of EQS Group AG. |