German contract development and manufacturing organisation Vetter, a specialist in aseptic filling, has completed the next stage of the expansion of its US early-stage development site on the Illinois Science + Technology Park in Chicago, with the addition of a third cleanroom.
Clinical syringe projects are now being accepted at the facility, which can handle preclinical to Phase II projects. The company says the overall 3,000m2 site offers all of the resources needed for early-stage clinical manufacturing, including chemical analysis and microbiology labs, material preparation and compounding functions. At the heart of the facility are its three cleanrooms, followed by visual inspection capabilities and GMP storage.
With the addition of the third cleanroom, filling of single-chamber syringes is now available with a maximum filling speed of 3,600 units/hour, and batch sizes up to 25,000 units. The line is constructed as a Restricted Access Barrier System (RABS), offering various filling pumps, as well as fully automated tub processing.
The newest cleanroom clinical manufacturing of syringes
The two existing cleanrooms, both operational since late 2011, provide fully automated vial filling for batches of up to 10,000 liquid or lyophilised 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, which mirrors the one located at the company’s European development operations in Ravensburg, Germany, expands upon its aim to offer customers early platform access to drug development.
'The newest cleanroom, which performs clinical manufacturing of syringes, is a demonstration of Vetter’s consistent approach to staying ahead of the market,' said Peter Soelkner, Managing Director of Vetter.
'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.'
