From preclinical development through commercial supply.
For more than 25 years, the Vetter name has stood for quality, innovation and strategic partnership.
An independent, leading provider of aseptically prefilled syringes, cartridges and vials, Vetter supports pharmaceutical and biotech clients throughout a product’s lifecycle, from preclinical development through regulatory approval and market supply worldwide.
Vetter is headquartered in Ravensburg, Germany.
Biotechnology drugs, in particular, are highly sensitive complex compounds that are very expensive to produce.
Vetter has extensive experience working with biotech substances, including monoclonal antibodies, peptides, interferons and vaccines. Types of stopper, types of glass, and degree of siliconisation can all potentially interact with a product’s active ingredient.
Knowing how to match drug product to delivery system is critical, along with designing an appropriate manufacturing process. So is maximising active pharmaceutical ingredient (API) yield. Vetter’s state-of-the-art technology preserves APIs during the filling process, and Vetter’s experience in the industry minimises wasteful trial and error.
Vetter is an acknowledged leader in aseptic filling. Its key features include:
• Vetter works with the world´s leading pharmaceutical and biotech companies
• Vetter is a leader in the use of restricted access barrier system (RABS)2 technology in cleanrooms
• Vetter invented dual-chamber technology, including the Vetter Lyo-Ject® dual-chamber syringe3 and V-LK® cartridge
• Vetter holds numerous patents on drug-delivery system processes and components
• Vetter is an expert in lyophilisation (freeze-drying), often required to prolong product shelf-life
Vetter’s services include:
• Vetter Development Service: product management from preclinical development to market launch
• Vetter Commercial Manufacturing: large-scale production and packaging of aseptic prefilled drug-delivery systems
• Vetter Solutions: proprietary innovations, from dual-chamber technology to anti-counterfeiting measures
Vetter supports clients on effective strategies for achieving multinational product approvals.
Approved as a foreign manufacturer by the Government of Japan, Vetter offers broad global regulatory experience, including support for numerous customer product approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Vetter has also worked with regulatory authorities in Canada, Russia, Brazil, Mexico, Saudi Arabia, Algeria, South Korea, Taiwan and Iran, among others.
Vetter’s services include:
• Project management: Across functions and facilities, throughout the development effort, Vetter teams communicate and coordinate using project management principles. This process-driven approach helps keep projects on track and timelines tight.
• Technology transfer: Development and commercial teams closely coordinate a product’s transfer from Vetter’s development labs to its large-scale manufacturing facilities. Vetter replicates commercial-stage processes in its early-stage laboratories to help prevent surprises at market production.
• Partnership: Client collaboration is one of Vetter’s distinguishing hallmarks. A close working relationship not only opens communication and instills trust, it helps prevent wrong turns and rework – which, in turn, helps save time and costs.
Vetter’s commercial manufacturing facilities include three aseptic filling operations and a state-of-the-art secondary packaging facility, which together represent a total capacity of up to 400 million production units per year.
Vetter production facilities work independently of each other and, to a large extent, have identical production processes, which enables them to serve as backup reserves, offering customers an extremely high degree of delivery and process security.
Vetter’s new Chicago facility supports small-batch preclinical through phase II products. At phase III, products will be transferred to Vetter’s commercial manufacturing facilities. Since two-thirds of early-stage development projects are located in North America, the Chicago site – an expansion of Vetter Development Service, represents Vetter’s strategic approach to serving the needs of its clients.
Vetter Pharma International GmbH
2RABS = restricted access barrier system, an innovation in contamination control
3Freeze-dried drug resides in one chamber; liquid in the other. Pushing the plunger mixes the two, reconstituting the drug. This prolongs shelf-life, promotes accurate dosing, and enables patients to self-administer.