The site currently offers 100,000 sqft of offices, laboratory space, areas for material preparation
Vetter, a global CDMO has further invested in additional capacity to meet growing demand for strategic support and resources for the development of injectable drug products.
One year following the purchase of a clinical manufacturing location in Rankweil, Austria, the site has been modified to the company’s standards for aseptic fill and finish in drug-delivery systems. “With this additional facility we will further expand our capability for early clinical development for phase I and phase II drug candidates,” said Vetter MD Peter Soelkner. “The dedicated manufacturing site will focus on supporting our customers on quality, timeliness and technical expertise.”
The site currently offers 100,000 sqft of offices, laboratory space, areas for material preparation as well as room temperature, cool and frozen storage and one automated vial filling line for liquid and lyophilised products.
“Through various measures and modifications, all systems and manufacturing processes have been successfully integrated into our business operations and the site is now ready for operations,” said Vetter MD Thomas Otto. “The site also offers opportunities for possible future expansion.”
In the coming months, media fills for different vial formats will be performed onsite to simulate the actual drug manufacturing process, representing an important step in preparing for future customers projects, Vetter says. “When establishing the new location, Vetter’s general expertise in aseptic manufacturing processes was, of course, very valuable,” said Dr Claus Feussner, Senior VP Vetter Development Service. “However, another major contributing factor was the know-how and experience we gained over the last ten years at our successfully established US Development Service facility in Chicago. These learnings will be incorporated into the customer business and future production for in-human trials in Rankweil.”
The next milestone for the clinical site will be official GMP inspection for obtaining the manufacturing license in the beginning of the fourth quarter 2021. The authority responsible for this site is the Austrian Federal Office for Safety in Health Care /Agency for Health and Food Safety.