Rentschler Fill Solutions commences GMP operations with the issuance of the pharmaceutical manufacturing authorization by the Austrian authority AGES

- The GMP compliance of the new, state-of-the-art facility at Rentschler Fill Solutions has been confirmed with the certificate from the Austrian Agency for Health and Nutrition Safety (AGES).
- The GMP-certified aseptic filling and freeze-drying have been operational since August 2018.

Rentschler Fill Solutions GmbH, a service company (Contract Development and Manufacturing Organization, CDMO) and expert in aseptic filling, received on August 20th the certificate for GMP compliance and the pharmaceutical manufacturing license for the European market from the Austrian Agency for Health and Nutrition Safety (AGES).

Rentschler Fill Solutions offers specialized Fill & Finish services for the international biotechnology and pharmaceutical industry, ranging from GMP-compliant aseptic filling and freeze-drying to comprehensive analytics. After completing the facility in a record time of just two years and obtaining GMP certification from AGES, Rentschler Fill Solutions is now a full-fledged player in the Fill & Finish service market, conveniently located in the heart of Europe. Using advanced aseptic filling technologies, several GMP batches have already been produced for customers.

The company, which focuses exclusively on contract development and manufacturing, fills pharmaceutical and biopharmaceutical products into vials ranging from 2 to 50 ml for clinical and commercial use. The facility is designed for flexible handling of small to medium-sized batches of up to 60,000 vials and offers a freeze-drying capacity of 15m2. Disposable materials ensure maximum product safety. Customers benefit from a comprehensive range of internal testing procedures, monitoring, and analytics. The facility is designed so that future expansions can be carried out without interrupting ongoing operations.

“Rentschler Fill Solutions is a modern, forward-looking Fill & Finish specialist with a high level of experience and process know-how from the initial clinical phases to successful commercialization. We design the best and most efficient solutions for each drug and support our customers in achieving their goals,” said Reinhold Elsässer, Managing Director of Rentschler Fill Solutions.

Together with the strategic partners Rentschler Biopharma SE and Leukocare AG, Rentschler Fill Solutions offers complete solutions from formulation development through active ingredient production to aseptic filling — all from a single source.

“Our joint promise `one contact – one contract – one quality` stands for our commitment to meet our customers' product and safety requirements and to open opportunities for accelerated market entry. The combination of reliable technology and customer-oriented processes, paired with the international experience of our experts, enables us to meet the high expectations of our customers and contribute to their success,” added Reinhold Elsässer.