Fast, flexible Fill & Finish solutions
Getting a drug approved and to market fast is one of the biggest challenges in our industry. Globalization and a highly competitive marketplace make speed and flexibility crucial to success. You need proven efficient solutions, advice you can trust, and a partner you can rely on.
As contract manufacturing organization, Rentschler Fill Solutions sets its complete focus on clients' projects and provides global biotech and pharmaceutical companies with expert fill & finish services ranging from GMP-compliant aseptic filling and freeze-drying to extensive analytics. Our facilities are top-of-class, and our experienced, highly knowledgeable team will guide you through every step, from first clinical phases to commercial supply to ensure product safety requirements are met and an expedited market entry is achieved.
What motivates us?
We take pride in powering your progress!
We are inspired by our clients’ innovative products, by our highly competent and motivated employees and partners. Together, we are able to achieve incredible breakthroughs. Last but not least the beautiful mountain landscape that surrounds our leading-edge facility plays its role.
This motivation empowers us to bring safe new drug products to market, making an important contribution to patient care every day.
Dr. Friedrich Sernetz has been appointed Chief Executive Officer at Rentschler Fill Solutions as of June 2019. Jochen Alberstetter took on responsibility as Managing Director Operations in April 2019.
Dr. Friedrich Sernetz studied chemistry in Freiburg and Gießen in Germany, and Stanford, USA and obtained his PhD in chemistry. With more than twenty years in the chemical and pharmaceutical industry, he provides in-depth experience in executive management and the strategic development of businesses. Over the course of his career he was in charge of Operations, Purchasing and Commercial / Sales as well as Country units at different international companies in Europe and Mexico.
Jochen Alberstetter studied packaging technology in Stuttgart, Germany. With many years as manager in the divisions Development, Supply Chain and Project Management, he provides extensive experience from the packaging and pharmaceutical industry, including fill and finish. Mr. Alberstetter joined the company from German Rentschler Biopharma SE where he served as Head of Strategic Alliance. In this role, he was responsible for the strategic collaboration between Rentschler Fill Solutions and Rentschler Biopharma.
Reliable from the beginning
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. All milestones were reached in quality, time and budget. With Rentschler Fill Solutions, a new center of excellence for aseptic filling has been created and is fully operational, located in the heart of Europe, in Rankweil/Austria.
Milestones of setting-up the new fill & finish facility:
|Sep 2015||Company founded|
|July 2016||Building construction started|
|Jan 2017||Technical facilities installation started|
|Feb 2017||Topping-out ceremony|
|Sep 2017||Administration moved-in, filling line and freeze dryer installed|
|Oct 2017||Installation qualification (IQ) of technical facilities started|
|Mrc 2018||Performance qualification (PQ) finished|
|Aug 2018||Certificate of GMP conformity and manufacturer’s authorization for the European market obtained from the Austrian Health Authority (AGES)|
|Sep 2018||GMP production|
Integrated company building for an optimized process flow
The integrated company building consists of three connected areas to optimally support process flows:
- Administration: offices and laboratories
- Production: engineering and production (batch preparation, material preparation, cleaning, sterilization, filling and freeze-drying)
- Logistics: warehouse, visual inspection and packaging
The concrete building includes a ground floor, a mezzanine and two upper floors with approx. 6000 m² of usable floor space. The building, including roof structures, is 16 meters tall. The property measuring approximately 10,000 m2 allows for expansion in several phases of construction without interrupting existing production.