Rentschler Fill Solutions GmbH, a contract development and manufacturing organization (CDMO) and expert for aseptic fill and finish services, obtained the certificate of GMP 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) on August, 20.
Rentschler Fill Solutions offers the international biotech and pharmaceutical industry specialist fill and finish services which range from GMP-compliant aseptic filling and freeze-drying to extensive analytics. With construction finished in the record time of only two years and the AGES GMP certification, Rentschler Fill Solutions is now a full player in the fill and finish services market, conveniently located in the heart of Europe.
Already, several GMP batches have been produced for customers, utilizing advanced aseptic filling technologies. Onsite, at the fully dedicated contract development and manufacturing organization, pharmaceutical and biopharmaceutical products are filled in vials of 2 to 50 ml for clinical and commercial use. The facility is designed for the flexible handling of small to medium sized batches of up to 60,000 vials and provides lyophilization capacity of 15m².
Single-use equipment guarantees maximum product safety. Clients profit from comprehensive in-house testing, monitoring and analytics. The facility is designed to enable future expansion without interrupting ongoing operations. “Rentschler Fill Solutions is a modern, forward-thinking fill and finish specialist with a high level of experience and process know-how, through every stage from the first clinical phases through commercial excellence. By designing the best and most efficient solutions for each drug product, we support our customers in achieving their goals,” said Reinhold Elsaesser, an Executive Manager of Rentschler Fill Solutions. Together with the strategic partners Rentschler Biopharma SE and Leukocare AG, Rentschler Fill Solutions offers end-to-end services – from formulation development through drug substance production to aseptic fill and finish, all from a single source.
“Our joint promise `one contact – one contract – one quality` represents our commitment to meet our clients’ product and safety requirements and to create the potential for expedited market entry. The combination of our reliable technology and customer-oriented processes with the international experience of our experts, enables us to satisfy the high expectations of our customers and power their progress,” Mr. Elsaesser added.
Rentschler Fill Solutions invites you to visit the company at the CPhI Worldwide conference in Madrid, October 9th-11th, 2018 at the joint booth of Life Sciences Austria (ICSE hall 3, booth 3D73).