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News|Articles|June 1, 2018
Rentschler Fill Solutions Announces Agreement for US-Market Drug
Author(s)Pharmaceutical Technology Editors
Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.
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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.
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