Scil Proteins Obtains EMA Approval for Commercial Production of Reteplase
Halle (Germany), 22 October 2012 - Scil Proteins Production GmbH, a private biotech company specializing in the research, development and production of recombinant proteins, announced today that the European Medicines Agency (EMA) has approved Scil Proteins’ Halle facilities for manufacturing of Reteplase, marketed by Actavis as Rapilysin®.
Scil Proteins originally signed an agreement with Roche in June 2008 for process transfer and manufacture of Reteplase and with this official EMA approval, Scil Proteins has successfully completed the site change from Roche. Reteplase is a recombinant protein for thrombolytic treatment of myocardial infarction.
Dr. Ulrike Fiedler, CEO of Scil Proteins, commented: “Our focus on quality enabled our experienced team of protein specialists to readily manage the manufacturing challenges of this complex biotherapeutic. We have the proven expertise and capacity to allow us to produce a number of advanced biotherapeutics and this EMA approval for our Halle facility is an important milestone for Scil Proteins.”
In addition to this agreement with Actavis, Scil Proteins has a diversified portfolio of contract development and manufacturing clients. To date, customers include Novartis, Sanofi, Dompé, Lundbeck, as well as other pharma and biotech companies.