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West and Vetter Collaborate to Offer Customers an Innovative Filling Solution for Biopharmaceutical Drugs

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Providing the best solution to the challenges of packaging and delivering today's sensitive and complex biopharmaceutical products requires not only a unique syringe system, but also the assurance that this system can be filled, handled and validated in accordance with appropriate cGMPs and pharmaceutical practices.

West and Vetter, a leading international independent specialist in the aseptic filling of drug-delivery systems, have collaborated to provide customers with the ability to source filled Daikyo Crystal Zenith® syringes.

To help customers transition to the Daikyo Crystal Zenith syringe system, West has been working extensively with Vetter. This relationship has allowed both companies to develop and optimize the manufacturing, validation and packaging of the syringe system to engineer compatibility with the filling capabilities and requirements at Vetter. Media fills and equipment validation are underway for the Daikyo Crystal Zenith 1mL long insert needle syringe system.

To support this initiative, investments have been made at Vetter's facilities in Germany and at their new Chicago facility. Capabilities will initially exist for early-phase clinical filling in Germany. Options for commercial-scale filling will be available.

"We are delighted to have the opportunity to offer our customers an innovative solution, combining the benefits of the Daikyo Crystal Zenith syringe system with the biopharmaceutical fill and finish capabilities of one of the world's leading contract development and manufacturing organizations," said Donald E. Morel, Jr., Ph.D., West's Chairman and CEO. "Vetter is an established market leader in the manufacture of aseptically prefilled drug-delivery systems for biopharmaceutical products, and we are pleased to have this ongoing relationship."

"We're pleased to partner with West on this advanced new technology," said Mr. Thomas Otto, Vetter Managing Director. "Vetter has always sought to stay at the forefront of innovation, so that we can serve the needs of our customers and the growing biotechnology industry."

Vetter is an international contract development and manufacturing organization (CDMO) specializing in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with a broad array of compounds, including monoclonal antibodies, peptides, interferons and vaccines.

An independent firm 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.

Visit Vetter online at http://www.vetter-pharma.com.

Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
Vetter is a registered trademark of Vetter Pharma-Fertigung GmbH& Co.KG in Germany, the United States and other jurisdictions.

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