© Rentschler Fill Solutions GmbH Employees #ShowForRare Rentschler: "We care for the rare”

February 2019. With this slogan the employees of Rentschler Fill Solutions GmbH at Rankweil (AT) show solidarity with the people suffering from rare diseases on 28 February 2019, the International Rare Diseases Day. At present, 6,000 to 8,000 rare diseases are known. In Austria more than 400,000 persons are affected. In Germany, around four million people and in the European Union around 30 million people are suffering from a rare disease.

As a full-service provider, Rentschler Fill Solutions accompanies innovative biotech and global pharmaceutical companies from investigations of their active substances in clinical studies up to marketing authorization and develops efficient filling processes. With an experienced team and state-of-the art technical facilities, the biopharma company speeds the progress of a medicine to market authorization and thus patient access to new therapeutic options. With the filling of already approved medications, including orphan drugs, Rentschler Fill Solutions as a highly specialized company assures availability of high-specificity and vital drugs for patients.

As the last link in the production chain with direct product contact, the employees bear great responsibility for ensuring the highest quality standards and sterility. With the aim of improving patients’ health worldwide, it’s worth giving your best every day.

 

Rentschler & Orphan Drugs
Comment by B2Bioworld

March 2019. Rentschler Fill Solutions (RFS) is the Austrian subsidiary of German Dr. Rentschler Holding GmbH & Co. KG. It received the GMP-license for the EU by Austrian AGES in August 2018. The first project of the new facility was finishing an orphan drug (vestronidase alfa/vjbk, trade name: Mepsevii) of US-German Ultragenyx Pharmaceutical which is manufactured by parent Rentschler Biopharma SE at Laupheim (DE) since December 2017. Vjbk received the European marketing authorisation in August 2018. It is a recombinant human beta-glucuronidase which targets non-neurological manifestations of the Sly Syndrome aka Mucopolysaccharidosis Type 7 (MPS 7), a rare paediatric disease. The drug is intravenously injected in dosages of 10 mg/5 mL. Rentschler prides itself of having wound up developing fill and finish for vbjk in record time until October 2018, an achievement which puts RFS ahead of competitor IOI Oleo GmbH. The latter company develops UX007 for Ultragenyx which received the European orphan medicinal product (OMP) designation in 2015. UX007 is a synthetic triheptanoine targeting long-chain fatty oxidation disorders (LC-FAOD) with potential to be expanded to treatment of common diseases such as neuropathy.

References

Bundesministerium für Gesundheit BMG (2015): Austrian National Action Plan for Rare Diseases (2014-2018) (in German). Februar.

European Commission EC (2018): Report on the operation of Directive 2011/24/EU on the application of patients' rsights in cross-border healthcare. Bruxelles, September 21: https://eur-lex.europa.eu/resource. html?uri=cellar:bc5ac6d2-bd7c-11e8-99ee-01aa75ed71a1.0019.02/DOC_1&format=PDF.

European Medicines Agency EMA (2019): EU/3/12/973 (Mepsevii – vestronidase alfa). Accessed March: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu312973.

Voigtländer T, Bachner F, Unterberger U, Leopold C, Ladurner J, Habl C (2012): Seltene Erkrankungen in Österreich. Wien, November: Commissioned by Bundesministerium für Gesundheit.

Sources: Rentschler Fill Solutions GmbH; Details added by B2Bioworld 

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