Vetter has announced its US early-stage development site located at the Illinois Science and Technology Park in 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 to Phase II projects.
The site offers the resources needed for efficient early-stage clinical manufacturing including chemical analysis, microbiology labs, material preparation and compounding functions.
The facility includes three cleanrooms, followed by visual inspection capabilities and GMP storage.
With the addition of the third cleanroom, filling of single-chamber syringes are 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 unique characteristics of the product, as well as fully automated tub processing.
The two existing cleanrooms, operational since 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.
The new cleanroom expands on the company’s strategy to offer its customers an early platform access to drug development.
Vetter offer biopharmaceutical companies the opportunity to utilise final packaging material, depending on individual product characteristics and planned launch strategy in early development phases.
Vetter managing director Peter Soelkner said: "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."
The first customer products in development were recently transferred from the early-stage Chicago facility to Vetter’s European sites for further Phase lll development and subsequent commercial production.
This shows the effectiveness of the company’s up scaling approach concept, as well as its acceptance by customers.
Several additional product transfers from early development in the US through to late stage development in Europe are planned for next year.