Rentschler Fill Solutions Announces Agreement for US-Market Drug

News
Article

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

Rentschler Fill Solutions GmbH announced on May 30, 2018 a collaboration with Ultragenyx Pharmaceutical, Inc. for the fill/finish 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, developed by Ultragenyx in collaboration with Rentschler Biopharma SE in Laupheim, Germany, was approved by the US FDA in November 2017. An application for marketing approval in Europe is under review.

The drug product will be transferred from Rentschler Biopharma SE to Austria-based Rentschler Fill Solutions for fill/finish activities. Rentschler Biopharma will continue to manufacture the drug substance.

Rentschler Fill Solutions offers services for the aseptic filling and freeze drying of drug products.

Source: Rentschler Fill Solutions

 

 

Recent Videos
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Related Content