Scil Proteins Production has received approval from the European Medicines Agency (EMA) to manufacture Reteplase, marketed by Actavis as Rapilysin, at its Halle facilities. Reteplase is a recombinant protein for thrombolytic treatment of myocardial infarction.
Scil Proteins originally signed an agreement with Roche in June 2008 for process transfer and manufacture of Reteplase and, with this approval, Scil has successfully completed the site change from Roche.
Dr. Ulrike Fiedler, chief executive officer 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' customers include Novartis, Sanofi, Dompé, Lundbeck, as well as other pharma and biotech companies.