Rentschler Fill Solutions GmbH opened the plant for the aseptic filling and freeze-drying of drug products intended for the European market.
The contract development and manufacturing organisation (CDMO) broke ground in Rankweil, Austria, in 2016. It received good manufacturing practice (GMP) certification and a European pharmaceutical manufacturing license from Austrian regulators in August 2018.
The company expects to receive US Food and Drug Administration (FDA) approval for the site in 2019.
“Together, we have successfully created an operational pharmaceutical business from scratch in record time,” said managing director, Reinhold Elsaesser, at the inauguration last week.
“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,” he added.
Rentschler Fill Solutions employs 59 employees and expects to increase headcount to 100 within the next two years.
In May of this year, the CDMO announced a service agreement with US-based Ultragenyx Pharmaceutical for commercial production.
According to the deal, Ultragenyx transferred fill/finish activities for injectable recombinant protein, Mepsevii (vestronidase alfa), from Rentschler Biopharma’s facility in Germany, to Rentschler Fill Solutions in Austria. The separate Rentschler companies are both owned by the Rentschler family.