Rentschler Fill Solutions GmbH has inaugurated its new state-of-the-art facility in Rankweil, Austria. The company hosted an entrepreneur’s event and opening ceremony with over 200 attendees, including customers, partners and local community representatives, to celebrate the launch of the new business.
 
“Today is a great day for us at Rentschler Fill Solutions and I would like to thank our team and our supporters for this achievement,” said Reinhold Elsaesser, managing director, Rentschler Fill Solutions. “Together, we have successfully created an operational pharmaceutical business from scratch in record time. We are now ready to help our clients bring unique active pharmaceutical ingredients to a global market. Very few companies in our region have this capability.”
 
In August, the company obtained the certificate of GMP (Good Manufacturing Practice)  compliance and the pharmaceutical manufacturing license for the European market from the Austrian Agency for Health and Food Safety (Agentur für Gesundheit und Ernährungssicherheit, AGES). From the laying of the first stone of the foundation in July 2016 to completion of the GMP approval in August 2018, the new facility was completed in two years.
 
Rentschler Fill Solutions expects approval from the U.S. Food and Drug Administration (FDA) in 2019. In May 2018, Rentschler Fill Solutions formed an agreement with its U.S. customer Ultragenyx Pharmaceutical, covering the fill and finish of an injectable recombinant protein, Mepsevii (vestronidase alfa), for U.S. commercial supply.
 
“It is not enough to develop innovative drugs. The capabilities and resources for production and filling are a crucial part of ensuring that new treatments are available for patients,” said Margit Klotz, general manager operations, Rentschler Fill Solutions. “Therefore, Rentschler Fill Solutions already has 59 highly skilled employees, and we intend to increase this number to one hundred by 2020.”
 
Rentschler Fill Solutions offers its clients fill and finish services for drug products on both a clinical and commercial scale. Through the strategic partnership of Rentschler Fill Solutions, Rentschler Biopharma and Leukocare, clients also benefit from one-stop solutions from gene to vial and clinic to market.