Opening ceremony of new high-tech facility for the aseptic filling and freeze-drying of drug products.
- Opening ceremony of new high-tech facility for the aseptic filling and freeze-drying of drug products.
- Pharmaceutical operations under GMP conditions for the European market already open for business.
Rankweil, Austria, November 16, 2018 – Rentschler Fill Solutions GmbH, a contract development and manufacturing organization (CDMO) and expert in aseptic fill and finish services, today officially 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 successful launch of the new business.
Reinhold Elsaesser, Managing Director of Rentschler Fill Solutions, commented: “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. 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 of Rentschler Fill Solutions – fully equipped with the latest technical infrastructure – was completed in the record time of two years.
Rentschler Fill Solutions expects approval from the US Food and Drug Administration (FDA) in 2019. In May 2018, Rentschler Fill Solutions announced an agreement with its US customer Ultragenyx Pharmaceutical, Inc., covering the fill and finish of an injectable recombinant protein, MepseviiTM(vestronidase alfa), for US 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,” Dr. Margit Klotz, General Manager Operations, added. “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.
About Rentschler Fill Solutions GmbH
Rentschler Fill Solutions GmbH, located in Rankweil, Austria, is a contract development and manufacturing organization (CDMO) for the aseptic filling of liquid and lyophilized pharmaceutical and biopharmaceutical products. With their complete focus on clients’ projects, the company provides state-of-the-art facilities which comply with the latest regulatory, quality and safety standards. Rentschler Fill Solutions focuses on delivering small to medium-sized batches, up to 60,000 vials, to meet clinical and market needs with its highly scalable solutions. Owned by the Rentschler family, Rentschler Fill Solutions is a company with a highly skilled team offering extensive experience and reliable services in aseptic filling. For further information, please visit www.rentschler-fill-solutions.
Contact:
Rentschler Fill Solutions GmbH
Andrea Kitzelmann
Expert Marketing
andrea.kitzelmann@rentschler-
Media Inquiries:
MC Services AG
Dr. Cora Kaiser
+49-89-210228-0
rentschler@mc-services.eu
