The recombinant protein will be produced in Halle, Germany
The European Medicines Agency (EMA) has approved Scil Proteins’ Halle, Germany facilities for the manufacture of Reteplase, which is marketed by Actavis as Rapilysin.
The private German biotech specialist in the research, development and production of recombinant proteins originally signed an agreement with Roche in June 2008 for process transfer and manufacture of Reteplase and with this approval from the European regulator, it has successfully completed the site change from Roche. Reteplase is a recombinant protein for thrombolytic treatment of myocardial infarction.
Ulrike Fiedler, CEO of Scil Proteins, said: ‘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.’