Vetter has received manufacturing authorization for a fill and finish site Austria, which the CDMO acquired in 2020.
Contract development and manufacturing organization (CDMO) Vetter bought the clinical production site in Rankweil, on the Austrian border with Switzerland and Liechenstein, from Impletio ‚Äď part of Rentschler, with which Vetter inked an alliance in July 2020.
The firm has been working to modify and equip all laboratory, technical and production areas at the 10,000 square-meter facility and has announced this week it is now officially authorized, meaning it can begin production for clinical projects following an inspection held by national regulatory authority the Austrian Agency for Health and Food Safety (AGES). The announcement comes a few weeks past the predicted timeline made by Vetter following the purchase in 2020.
‚ÄúFor pharmaceutical companies and their service providers, it has to be the ultimate goal to fully comply with the regulations of GMP. This ensures the quality of the manufactured medicinal products and therefore also the patient safety,‚ÄĚ said Wolfgang Weikmann, Vetter‚Äôs SVP of Quality Assurance and Quality Control.
‚ÄúThe 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.‚ÄĚ