Press Release
2016-06-07
Xbrane Biopharma AB has entered into an agreement with Biotechpharma UAB regarding scale-up of the production of Xlucane, Xbrane's Ranibizumab biosimilar, in GMP approved facility, further process optimization, the required biochemical characterization and development of the CMC documentation.
"The development of Xlucane has proceeded faster than expected, enabling us to proceed from process development in pilot scale earlier than planned. We are pleased to take the step into production of Xlucane in a by EMA GMP certified facility. This ensures us to get the material and the head-to-head in-vitro comparability study required to initiate clinical trials. We have reached an important milestone in taking our first biosimilar into GMP production", says Martin Åmark, CEO of Xbrane Biopharma AB."
"We are proud to help Xbrane to achieve its goals and to enter clinical trials rapidly", comments Vladas Bumelis, CEO Biotechpharma. "The Xlucane-project fits perfectly to our capabilities to manufacture high-quality biopharmaceuticals in our cGMP-certified production plant and to execute the broad analytical characterization based on Biotechpharma's extensive experience in this field", adds André Markmann, VP Business Development.
About Xbrane
Xbrane is a commercial phase Swedish biopharmaceutical company specialized in High Demand Complex Generics. Xbrane has world leading expertise in developing generics for injectable controlled release drugs and proprietary high-yield protein expression technology for the development of biosimilars. The goal is to become a global leader within the company's portfolio of High Demand Complex Generics. Xbranes's headquarter is located in Stockholm and the company's in-house research and development facilities are in Sweden and Italy. Xbrane is listed at Nasdaq First North since February 3rd under the name XBRANE and Avanza Bank AB is Xbrane's certified advisor. For more information see www.xbrane.com.
For further information, please contact:
Martin Åmark, Chief Executive Officer
M: +46 (0) 763-093 777
E: martin.amark@xbrane.com
About Biotechpharma UAB
Biotechpharma UAB is a leading biopharmaceutical CDMO CMO providing fully integrated process development and GMP-manufacturing services globally. Biotechpharma has extensive experience in the production of biosimilars and new biological entities, having 135 employees at its state-of-the-art facility in Vilnius, Lithuania.
For further information, please contact:
Dr. André Markmann, VP Business Development
bd@biotechpharma.lt
www.biotechpharma.lt
