Vetter says it will reduce API wastage through its new US production facility for the filling of syringes, cartridges and vials.
Based at the Illinois Science and technology Park, Chicago, the 24,000-square-foot site is the German contract development and manufacturing organization’s (CDMO) first in America.
The site includes microbiology and chemical analysis labs, material preparation and compounding functions, three cleanrooms for aseptic filling, and visual inspection, and will premier Bosch’s new MHI 2020 B fully automated vial filler.
And the machinery performs a 100 percent in-line check-weigh system to ensure accurate fill volume, eliminating the need for sampling to verify volume which, Vetter is confident, will reduce API wastage.
Other streamlining features include minimum tubing lengths, and the use of disposable components in material preparation, compounding and filtration areas – which eliminates the need for cleaning validation.
The business says its automated vial filler can run up to 10,000 liquid or 6,000 lyophilized vials per batch, and the semi-automated 500 units per batch.
Expanding in the US
The new plant comes as part of Vetters plans to expand its reach within the US market, where nearly half of its clients are based.
Vetter MD Peter Soelkner said: “Our Chicago facility provides customers with a top-of-the-line clinical manufacturing site located in the heart of the United States.”
Last year the firm also signed a packaging agreement with Indiana-based Sentry BioPharma Services.
When asked about potential partnerships, Vetter were unavailable for comment.