Vetter’s New Clinical Manufacturing Site Now Fully Integrated
- Expansion of clinical capacity to address growing market demand
- Site status now ‘ready for media fill’
- Next milestone – approval of Austrian authority
RAVENSBURG, Germany and RANKWEIL, Austria, July 21, 2021 / B3C newswire / -- A growing number of pharmaceutical and biotech companies are seeking clinical manufacturing partners that provide strategic support and comprehensive resources for their development process of new, promising injectable drug products. Vetter, a leading global Contract Development and Manufacturing Organization (CDMO) has further invested in additional capacity to meet this growing global demand.
Only one year after the purchase of the clinical manufacturing location in Rankweil, Austria, the site has been modified to the high Vetter quality standards in aseptic fill and finish for 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,” says Vetter Managing Director Peter Soelkner. “The dedicated manufacturing site will focus on supporting our customers on quality, timeliness and technical expertise.”
The production site currently offers 100,000 square feet 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 lyophilized 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,“ explains Vetter Managing Director 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 that simulate the actual drug manufacturing process and represent an important step in preparing for future customers projects. “When establishing the new location, Vetter’s general expertise in aseptic manufacturing processes was, of course, very valuable,” outlines Dr. Claus Feussner, Senior Vice President 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 new clinical site will be the 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 BASG / AGES (Federal Office for Safety in Health Care /Agency for Health and Food Safety).
Headquartered in Ravensburg, Germany, Vetter is a family-owned, global leading contract development and manufacturing organization (CDMO) with production facilities in Germany, Austria and the United States. Currently employing more than 5,500 individuals worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Great importance is also given to social responsibility including environmental protection and sustainability.
Vetter Pharma International GmbH
Corporate Spokesperson / Media Relations