Vetter, a leading provider of aseptic pre-filled drug-delivery systems, announced today that cleanroom infrastructure will be completed by early May at its new Chicago facility, an expansion of Vetter Development Service (VDS), and the site remains on schedule for launch of operations at the beginning of the fourth quarter 2010.
Cleanrooms at VDS Chicago
VDS Chicago is located at the Illinois Science and Technology Park in suburban Chicago and will support pre-clinical through phase II development projects. The state-of-the-art facility includes 24,000ft² of microbiology and chemical laboratories, and three cleanrooms, whose infrastructure will soon be finished, including the installation of monitoring and laminar airflow equipment. Vetter will be installing filling units over the coming months, and the site will be operational in beginning of the fourth quarter 2010.
First-of-its-kind Bosch filling unit – first at Vetter
One cleanroom will house Bosch’s new MHI 2020 automated vial filler. Vetter is the first company to use Bosch’s new system, which was designed specifically for clinical-stage, high-value biopharmaceuticals. The unit will fill up to 10,000 liquid or 5,000 lyophilized vials per day.
Semi-automated filling capacity
A second cleanroom offers semi-automated filling of up to 500 units per day. The system can fill a variety of packaging materials, including vials, syringes and cartridges. This cleanroom is intended for liquid fills, although the unit may also perform fills for non-cGMP lyophilised units. Filling operations in the third cleanroom are planned for pre-sterilised syringes.
Vetter at BIO
As part of the 2010 BIO International Convention’s Contract Services Summit, Dr Claudia Roth, site manager of Vetter’s new Chicago facility, will present ‘Design and implementation of a fast and flexible clinical-trial-material manufacturing site in the US’ on 4 May from approximately 3pm to 3:30pm CDT. She will discuss approaches to clinical manufacturing developed by Vetter, from the
focus on disposable technology, to minimising API losses via automated sample filling, to rapid implementation of manufacturing processes. BIO is being held at McCormick Place in Chicago, 3 to 6 May. On the exhibit floor, Vetter’s booth is number 2351. Vetter is also an active participant at the Illinois Pavilion at booth number 3302.