Vetter Development Service August 2011

Vetter, a leading provider of aseptically prefilled drug-delivery systems, launched a new state-of-the-art facility at the Illinois Science + Technology Park in suburban Chicago. The site offers a central US location with a domestic and international airline hub. Moreover, it is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure, prominent research institutions, and a talent pool of 70,000–80,000 professionals.

An expansion of Vetter Development Service, the Chicago site supports preclinical through phase IIdevelopment projects. The 24,000-ft² facility’s functional areas include microbiology and chemical analysis laboratories; materials preparation; compounding; aseptic CGMP filling for vials, syringes, and cartridges; quality assurance; and seamless transfer to Vetter Commercial Manufacturing.

Early Phase Work

Developed at the urging of Vetter’s North American clients, the Chicago site supports small-batch, early stage products. Vetter has extensive experience working with biologics, including monoclonal antibodies, peptides, interferons, and vaccines. Type of stopper or glass and degree of siliconization can potentially interact with a product’s active ingredient. Matching drug product to delivery system and manufacturing process is critical. So is maximizing API. Vetter’s state-of-the-art technology preserves APIduring the filling process, and its experience in the industry minimizes wasteful trial and error.

Supporting a Faster Time to Market

The Chicago facility provides the Vetter approach to product development, which enables a smooth continuum throughout a product’s lifecycle.

Project Management: Across functions and facilities, throughout the development effort, Vetter teams communicate and coordinate using project-management principles. Such a process-driven approach helps keeps projects on track and timelines tight. Experienced project managers steer all tasks and processes, which is especially critical in early phase work.

Technology Transfer: Development and commercial teams closely coordinate a product’s transfer from Chicago labs to Vetter’s large-scale manufacturing facilities. The Chicago facility already replicates commercial-stage processes to help prevent surprises at market production.

Partnership: Client collaboration is one of Vetter’s distinguishing hallmarks. Vetter works closely with its clients to plan not only for the present, but to set a successful course through registration and long-term market production.

Expanding Development Services to Chicago

Vetter’s new Chicago facility is an expansion of Vetter Development Service, which 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 primary and secondary packaging development, process development, clinical manufacturing, pharmaceutical analysis, regulatory affairs services, and seamless product transfer to Vetter Commercial Manufacturing.

Vetter at a Glance

Vetter is an independent international specialist in the aseptic filling of syringes, cartridges and vials. With approximately 2,400 employees worldwide, Vetter holds nearly 140 patents and has longstanding experience in working with regulatory authorities around the world.

Vetter’s international success arises from its three interdependent divisions:

About the Author

Author Details
Peter Soelkner is managing director of Vetter Pharma International GmbH, Eywiesenstrasse 5, 88212 Ravensburg, Germany; 49-751-3700-0, fax: 49-751-3700-4000; [email protected]; www.vetter-pharma.com