Alvotech, today announces the opening of a new state-of-the-art facility, dedicated to the development and manufacturing of biosimilar monoclonal antibodies (“mAbs”). The opening of this industry leading biologics manufacturing plant marks a significant milestone for Alvotech, an independent sister company of the global pharmaceuticals company Alvogen.
Alvotech has worked with the U.S. FDA and European (EMA) regulatory agencies to design and build a facility complying with the highest quality standards. The manufacturing process is based on 1,000L and 2,000L single-use bioreactor fermentation design and has a total capacity of 16,000L laid out in two independent up- and downstream areas. The 13,000 square meter facility which is located in the science park of the University of Iceland in Reykjavik, also houses fully automated vial and syringe filling capabilities as well as quality control labs. Iceland offers a favorable operating environment with a strong regulatory system and a convenient geographical location.
Alvotech’s initial pipeline comprises six biosimilar mAbs which will be brought to market after patents expire. The company currently runs five offices in Iceland, Germany, Switzerland and Malta, employing almost 200 people led by a highly specialized and dedicated management team.