Vetter Pharma International GmbH

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 to 80,000 professionals. An expansion of Vetter Development Service, the Chicago site supports pre-clinical through phase II development projects. The 24,000-foot facility’s functional areas include microbiology and chemical analysis lab; materials preparation; compounding; aseptic cGMP filling for vials, syringes, and cartridges; quality assurance; and seamless transfer to Vetter Commercial Manufacturing.

Early-phase work
DeveIoped 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 and other complex compounds, 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 API during 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
Vetter’s new Chicago facility is an expansion of Vetter Development Service, which employs more than 125 personnel in Europe and the United States and supports customer products from preclinical development through market launch. Its service portfolio offers a full menu of fill-finish capabilities for early and late stage of clinical trial materials including:

• Primary packaging development. In close collaboration with customers, we select the drug-delivery system that suits each product. Vetter also offers counsel on secondary packaging components, technical processes and quality requirements
• Process development. Design of a product-specific manufacturing process and comprehensive feasibility and quality testing to assess specific dosage forms over time
• Clinical manufacturing. Compounding and production of clinical trial materials in the quantities required for early- and late-stage molecule development
• Pharmaceutical analysis. Quality control of raw materials, packaging materials, bulk solutions, in-process materials, and finished product
• Regulatory affairs services. Preparation of required documents for international regulatory approval, per client specifications. Regulatory services support is provided throughout the registration process
• Transfer to Vetter Commercial Manufacturing. Selection of the appropriate methods for commercial drug production

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:

• Vetter Development Service specializes in taking complex compounds from preclinical development to regulatory approval and worldwide market launch.
• Vetter Commercial Manufacturing performs the entire production process, from compounding and aseptic filling to final product packaging.
• Vetter Solutions’ innovative patented drug-delivery and anti-counterfeiting systems help clients to compete more effectively throughout the world.