Contract development and manufacturing organization (CDMO) has announced it has achieved its first customer fills at its new clinical manufacturing facility in Rankweil, Austria. According to the company, the facility also has additional customer batches in the works, other projects are in its pipeline, and the firm plans to expand the site to help in optimization of processes as well as increasing of its production capabilities.
Vetter initially purchased the Rankweil facility in mid-2020 in order to help meet growing customer demand for complex fill and finish solutions in early drug development phases. It also was anticipated to serve as the European counterpart to the company’s clinical manufacturing site already situated in the US, near Chicago.
The company reports that within one year of its purchase, the site was adapted and integrated to meet Vetter’s quality standards. In December of 2021, successful completion of cGMP inspection by the responsible national regulatory authority, the Austrian Agency for Health and Food Safety (AGES), reportedly was achieved thus allowing the facility to support clinical development projects of global pharmaceutical and biotech companies.
“We have been highly focused on achieving the strategic integration of the site,” said Martin Schwab, site head of Austria. “With hard work and focus, we have managed to get the site fully operational quickly and are already planning for expansion and further development."
With the goal of offering customers additional production capacities, a second autoclave and another washing machine for material preparation will be implemented in the next few months, as well as a modification of the current lyophilizer to become consistent with its Ravensburg facilities, allowing for an optimized aligning of systems and processes. This reportedly will support, for instance, the transition from clinical to commercial production within Vetter.
Andrea Wesp, vice president for new business development, added, "Our intent is to support global customer projects as best as we can by offering a flexible and holistic service portfolio for clinical manufacturing. The positive feedback we have received from customers so far who have already visited our Rankweil site is not only proof that we are meeting their needs but that we have achieved an important step in our business strategy."