The clinical manufacturing facility of Vetter receives a permanent operating license

High quality standards in aseptic production at the clinical Vetter site in Vorarlberg, Austria. © Vetter Pharma International GmbH

– Successful Re-Inspection of the New Location for Clinical Development in Austria
– Inspectors Were Impressed by Systems and Processes
– Rankweil Offers Services for the Manufacturing and Testing of Clinical Trial Preparations

Vetter, a globally leading Contract Development and Manufacturing Organization (CDMO), has received the indefinite operating license for the clinical development site in Rankweil, Austria. Representatives of the Agency for Health and Nutrition Safety (AGES) conducted another inspection of the site. Prior to commissioning, the authority had already carried out an initial inspection at the end of 2021, during which – as is customary in Austria – a temporary operating license was issued for two years.

During the multi-day inspection, AGES representatives gained detailed insights into Vetter's operations at the site. The focus was on reviewing workflows and documentation in production and quality control, as well as the quality assurance systems. The inspectors were impressed by the condition of the facilities, the structured processes, and the professional expertise of the staff.

“We are very satisfied and proud of the results of the comprehensive inspection by AGES. Our state-of-the-art location in Austria is characterized by clearly structured and modern systems and processes, and our employees possess a high level of expertise,” says Wolfgang Weikmann, Senior Vice President of Quality at Vetter. “This allows us to support our customers and their patients worldwide with the manufacturing and testing of clinical trial preparations of consistently high quality.”

The clinical manufacturing site in Vorarlberg, Austria, is the European counterpart to the existing production site near Chicago. “With our Rankweil location, we are further expanding our international presence in process development as well as in the production of injectable drugs in the development stage,” says Dr. Claus Feussner, Senior Vice President of Development Service at Vetter. “The successful re-inspection and the receipt of the indefinite operating license for the site is another important milestone in our strategic corporate development.”