Vetter, a global leader in the fill and finish of aseptically prefilled syringe systems,  announced that its US early-stage development site located at the Illinois Science + Technology Park in suburban Chicago, has completed the next step of its expansion with the addition of a third cleanroom. Clinical syringe projects are now being accepted at the facility, which can handle preclinical through phase II projects. The overall 30,000-square-foot site offers all of the resources needed for efficient early-stage clinical manufacturing, 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.  Recent facility expansion offers new manufacturing options and additional filling capacity.

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.

New cleanroom completes company’s platform offering in its Chicago facility
The new cleanroom, which mirrors one already available in the company’s European development operations in Ravensburg, Germany, expands upon the company’s strategy to offer its customers an early platform access to drug development. By being able to realize the clinical manufacturing of prefilled vials, syringes, and cartridges in Chicago, Vetter can offer (bio-)pharmaceutical companies to utilize the final packaging material, depending upon the individual product characteristics and planned launch strategy already in the early development phases.

Said Vetter Managing Director Peter Soelkner, “The newest cleanroom, which performs clinical manufacturing of syringes, is a demonstration of Vetter’s consistent approach to staying ahead of the market. For many indications, prefilled syringes provide advantages that will become even more important in the future of drug delivery. With our Chicago site, we can now offer our customers filling of this delivery system from early in the drug development process, affording them an innovative approach and an early advantage in today’s highly competitive markets.”

Recently, the first customer products in development were transferred from the early-stage Chicago facility to Vetter’s European sites for further Phase lll development and subsequent commercial production, signaling the effectiveness of the company’s upscaling approach concept as well as its acceptance by customers. Several additional product transfers from early development in the U.S. through to late stage development in Europe are planned for the upcoming year.