Rentschler Fill Solutions has inaugurated a €30 million ($34 million) fill & finish facility in Austria. The site will produce Mepsevii (vestronidase alfa) drug product for Ultragenyx Pharmaceutical.
Construction of the facility began in July 2016, and the plant received GMP approval in August this year. But today (Friday) the contract development and manufacturing organization (CDMO) officially inaugurated the facility in Rankweil, Austria.
The clinical and commercial plant forms part of Rentschler Biotechnologie’s strategic alliance with Leukocare, which aims to offer formulation development, drug substance production and aseptic fill and finish, all from a single source.
“The overall capacity will be approximately 3.5 million vials per year,” Reinhold Elsaesser, managing director of Rentschler Fill Solutions told BioProcess Insider.
The firm focuses on delivering small to medium-sized batches of up to 60,000 2ml vials, he added, and part of the new capacity will be used for the recombinant protein Mepsevii (vestronidase alfa) after Rentschler inked a deal to supply the US commercial drug product with Ultragenyx Pharmaceutical back in May. The validation batches of Mepsevii are planned for 2019, Elsaesser confirmed.
The opening of the plant will help ease the demand for fill and finish services for biologics.
“There is a lack of capacity in the industry, especially for freeze-drying,” said Elsaesser.
“We are in our ramp-up phase which means that we will constantly increase the capacity step-by-step from currently one batch per week up to one batch per day by 2020. Therefore, we are happy to welcome new customers.”
The plant currently employs 60 staff but this is expected to increase to 100 by 2020.