Staffing strategy ensures consistent quality and processes
Ravensburg, Germany / Skokie, USA, April 28, 2011 / B3C newswire / – Vetter, a leading provider of aseptic prefilled drug-delivery systems, today announced that its Chicago facility is accepting client projects. Located at the Illinois Science + Technology Park in Skokie, Illinois, the site supports preclinical through phase II products. The facility provides cGMP filling for vials, syringes and cartridges. Processes used at Vetter’s Chicago operations are based on those of existing Vetter facilities. The site is staffed in large part by experienced professionals from Vetter’s German facilities. Some of these personnel will be replaced by local professionals as they are hired and trained in Vetter best practices. This train-and-replace strategy helps ensure seamless performance across Vetter sites.
Chicago facility functional areas include qualification and validation, engineering, microbiology lab, chemical analysis lab, materials preparation, compounding, aseptic filling, visual inspection, quality assurance, supply chain and the administrative office. German employees currently staff a majority of positions, while local professionals are hired and trained. Local staff hired to work in the microbiology and chemical analysis labs receive part of their training at Vetter’s existing facilities. Those working in the manufacturing area train on local equipment at the Chicago facility. Experienced project managers steer all tasks and processes, which is a major success factor in early-phase work.
Over the next two to three years, local professionals are expected to replace some of Vetter’s German employees in Chicago. “Our train-and-replace strategy underscores Vetter’s dedication to consistency and quality, which our customers trust us to deliver,” explains Vetter Managing Director Peter Soelkner. “This approach also helps ensure a seamless transfer from Chicago to our commercial manufacturing facilities, once products reach phase III.”
The 24,000-square-foot Chicago facility houses cleanrooms, chemical analysis lab, microbiology lab, cGMP storage area and administrative offices. It is located in a thriving industrial and academic center that offers a talent pool of 70,000 to 80,000 highly skilled professionals. Site manager Dr. Claudia Roth has extensive experience designing and establishing clinical manufacturing lines, including freeze-drying operations.
Vetter´s new Chicago facility is an expansion of Vetter Development Service, one of the company’s three service divisions, along with Vetter Commercial Manufacturing and Vetter Solutions. Vetter Development Service employs more than 100 personnel in Europe and the United States and supports customer products from preclinical development through market launch. Its service portfolio includes, among others, primary and secondary packaging development, process development, clinical manufacturing, regulatory affairs services, and seamless product transfer to Vetter Commercial Manufacturing.
Last year, Vetter relocated its North American sales office to the Illinois Science + Technology Park, further enhancing the company’s ability to serve its customers quickly and efficiently. Proximity to major airports and a metropolitan train station at the park, coming soon, enables customers easy access and underscores Vetter’s emphasis on partnership and its dedication to serving the North American market.
About Vetter - www.vetter-pharma.com
Vetter is an independent international specialist in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with a broad array of substances, including monoclonal antibodies, peptides, interferons and vaccines. Headquartered in Ravensburg, Germany, Vetter provides support for pharmaceutical and biotech clients from preclinical development through regulatory approval and global market supply. Vetter’s new Chicago facility, an expansion of Vetter Development Service, supports early-stage products. The firm works with the world’s leading pharmaceutical and biotech companies, and employs approx. 2,400 staff across Europe and the United States. The innovator of the Vetter Lyo-Ject® dual-chamber syringe and V-LK® cartridge, the company holds nearly 140 patents and is a leader in the use of RABS technology in cleanrooms. Approved as a foreign manufacturer by the government of Japan, Vetter’s global regulatory experience includes numerous customer product approvals by the FDA, EMA and other authorities. Over its more than 25-year history in aseptic filling, Vetter has won many awards for its facilities and operations, including the 2010 SAP EMEA Quality Award, silver medal, for the implementation of a companywide planning software system.
For more information contact:
Vetter Pharma International GmbH