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Vetter has added a third cleanroom as part of an expansion of its US early-stage development site at the Illinois Science and Technology Park in suburban Chicago.
Vetter, a CDMO specializing in aseptic filling, announced that it has added a third cleanroom as part of an expansion of its US early-stage development site at the Illinois Science and Technology Park in suburban Chicago.
The overall 30,000-square-foot site has the capabilities needed for early-stage clinical manufacturing (i.e., preclinical to Phase II), including chemical analysis and microbiology labs, material preparation, and compounding functions. At the heart of the facility is its three cleanrooms, followed by visual inspection capabilities and GMP storage.
With the recent addition of the third cleanroom, filling of single-chamber syringes is now available with a maximum filling speed of 3,600 units per hour, and batch sizes as large as 25,000 units. The line is constructed as a restricted access barrier system (RABS), offering various filling pumps depending upon products unique characteristics, as well as fully automated tub processing. The two existing cleanrooms, both operational since late 2011, provide fully automated vial filling for batches up to 10,000 liquid or lyophilized vials, as well as semi-automated filling for manufacturing prefilled syringes, cartridges, and vials in small batch sizes of a few hundred.
The new cleanroom is similar to the one in Vetter’s European development operations in Ravensburg, Germany. With this expansion at the Chicago facility, customers can have access to an early drug development platform. By being able to realize the clinical manufacturing of prefilled vials, syringes, and cartridges in Chicago, bio/pharmaceutical companies will be able to utilize the final packaging material, depending upon the individual product characteristics, and planned launch strategy already in the early development phases.