Vetter’s new clinical manufacturing site now officially authorized

Aseptische Abfüllung eines Wirkstoffes in Vials bei Vetter. (Bildquelle: Vetter Pharma International GmbH) / (Photo: Vetter Pharma International GmbH)

– Important milestone reached for the new site
– Additional filling capacities for early-stage clinical development
– First customer audits already completed

Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has received the manufacturing authorization for its new site in Rankweil, Austria. As a result of the successful inspection held by the responsible national regulatory authority, the Austrian Agency for Health and Food Safety (AGES), the site can now support clinical development projects of international pharmaceutical and biotech companies. The service provider had purchased the approximately 10,000 square meters manufacturing facility in 2020.

Vetter Development Service Rankweil represents the company’s European counterpart to its existing clinical manufacturing site near Chicago. With the new site further expanding its international presence, Vetter is responding to the growing global demand for fill & finish services. The Austrian facility increases the company's capacity in the important field of process development as well as clinical manufacturing of Phase I and II injectables for customers.

"We are consistently investing in the expansion of our development and filling capacities," says Dr. Claus Feussner, Senior Vice President Vetter Development Service. "Our ambition is to support our customers in the best possible way on their journey to develop promising new therapies for patients. The site's approval is an important step in our strategic company development."

Since acquiring the Rankweil site in the middle of 2020, Vetter has modified and equipped all laboratory, technical and production areas to its high-quality standards. In addition, the company optimized numerous systems and processes.

"For pharmaceutical companies and their service providers, it has to be the ultimate goal to fully comply with the regulations of "Good Manufacturing Practices” (GMP). This ensures the quality of the manufactured medicinal products and therefore also the patient safety," adds Wolfgang Weikmann, Vetter’s Senior Vice President of Quality Assurance and Quality Control. "The comprehensive inspection conducted by the AGES revealed that the systems and processes implemented at the Rankweil site are fully capable to fulfill the high quality requirements.”

The successfully completed cGMP inspection by AGES enables the new clinical manufacturing facility in Rankweil to officially start operations and to realize customer projects in the clinical development phase on their way to approval. First customers have already performed initial visits and audits at the new site.