Vetter's new location for clinical development now fully integrated

One year after acquiring the development site in Rankweil, Austria, all systems and processes have been successfully integrated, and the site is operational.

With a distance of only one hour by car to Vetter's headquarters in Ravensburg, the new location is well positioned to be a successful extension of Vetter's existing clinical development in the future.

– Expansion of clinical filling capacities in response to increasing market demand
– Site has achieved 'Ready for Mediafill' status
– Next milestone: Approval from the Austrian regulatory authority

More and more pharmaceutical and biotech companies are relying on competent partners who offer strategic support and product-specific fill & finish solutions for the clinical development of their highly specialized active ingredients. Vetter, a leading Contract Development and Manufacturing Organization (CDMO), is responding to the growing global demand by expanding its development service capacities.

Just about a year after acquiring the site for clinical development in Rankweil, Austria, it was upgraded to meet Vetter's high-quality standards applicable for the aseptic filling of medications into injection systems. "With this additional site, we will further expand our capacities for early clinical development in Phase I and Phase II of promising therapies," says Vetter CEO Peter Sölkner. "The production site mainly provides our customers with support in process development, quality, and technical expertise."

The Austrian site currently offers 10,000 m2 of space for laboratories and material preparation, facilities for room temperature, refrigerated, and deep-frozen storage, offices, and an automated vial filling line for the production of liquid and lyophilized medicines. "Through the implementation of numerous measures, all systems and manufacturing processes have been successfully integrated into our Vetter business operations, and the site is now operational," explains Vetter CEO Thomas Otto. "For potential expansion in the future, the site was designed with unused areas within the existing building. There is also still the possibility to further expand the building itself."

In the coming months, media fills for various vial formats will be conducted on-site, simulating the actual manufacturing process of medicines and representing an important step in preparing for future customer projects. "When setting up the new site, our comprehensive expertise in aseptic manufacturing processes was very valuable," explains Dr. Claus Feußner, Senior Vice President of Vetter Development Service. "But above all, the know-how and experience we have gained over the past ten years at our successfully established development site in the USA made a significant contribution. These insights will also be incorporated into future customer projects in Rankweil."

The next milestone for the new site will be the official GMP inspection to obtain the operating license, expected to take place at the beginning of Q4 2021. The responsible authority for this is the Austrian BASG/AGES (Federal Office for Safety in Health Care / Agency for Health and Food Safety).