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, validated and approved in accordance with appropriate cGMPs and pharmaceutical practices.
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 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.”
West will exhibit the Daikyo Crystal Zenith and other prefillable syringe systems at the 2011 PDA Europe conference, The Universe of Pre-filled Syringes and Injection Devices, in Basel, Switzerland, November 7-11, 2011. Christa Jansen-Otten, Director Prefillable Syringe Platform, Europe for West, will participate in a seminar on pre-filled syringe materials on November 9 at 7:45 a.m.