The early-stage development site within the Illinois Science and Technology Park can now handle sterile injectable projects from pre-clinical to Phase II.
Vetter’s 30,000 sq ft US premises include chemical analysis and microbiology labs, units for material preparation and compounding, three cleanrooms, visual inspection areas and GMP storage.
The recent addition of a third cleanroom means the company will be able to fill single-chamber syringes at a maximum speed of 3,600 units per hour at batch sizes up to 25,000 units.
The filling line is constructed as a Restricted Access Barrier System (RABS), with changeable pumps according to product, as well as automated tub processing.
The two existing cleanrooms, operational since late 2011, perform automated vial filling for batches of up to 10,000 liquid or lyophilized vials, and semi-automated filling for manufacturing prefilled syringes, cartridges, and vials in smaller batch sizes of a few hundred.
Vetter said its syringe-filling operations will allow customers to use their final packaging material during clinical stage production, meaning they can plan their commercial launch strategy in the early development phase.
The latest cleanroom mirrors Vetter’s existing one in Ravensburg, Germany. The company’s European sites are capable of Phase III and commercial production. Vetter said it recently performed its first product transfer of early-stage drugs at the Chicago facility over to Germany for later-stage manufacturing, and plans several more transfers in 2015.
Managing Director Peter Soelkner said the expansion “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.”
Reports indicate the market for pre-filled syringes is slowly increasing, with richer countries quicker to adopt them. But emerging markets are expected to increase their demand above that from the US and Europe by 2024, one report found.