West Completes Preliminary Study Evaluating the SmartDose Electronic Patch Injector Technology Platform, Which Incorporates a Daikyo Crystal Zenith Cartridge
EXTON, Pa., Nov. 7, 2013 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, has completed a preliminary study of its SmartDose® technology platform, which incorporates a Daikyo Crystal Zenith® (CZ) cartridge. The study evaluated multiple attributes of the technology and subjects' experience with the self-application process.
The June 2013 study, entitled "First-in-Man, Single Center, Open, Two Periods, Self-Application Clinical Study to Evaluate the Safety, Performance and Tolerability of SmartDose 2.5 Using Saline in Healthy Subjects at Two Delivery Rates," was conducted in Israel in ten healthy male study subjects.
"We believe our efforts to develop the SmartDose technology platform system are important, because we see an unmet need for high-volume subcutaneous delivery of viscous or sensitive drug products, which may require longer injection times," said Paul Norton, Vice President of Self-Injection Systems at West.
"Daikyo Crystal Zenith has a long history of use as a primary drug container, and many of our customers find Daikyo Crystal Zenith an attractive option based on quality, stability and performance considerations. The flexibility of CZ allows it to be optimized for use with the SmartDose platform and makes it possible to utilize these technologies for the next generation of self-administered protein-based drugs.
"This is an important step as we seek to develop a complete drug delivery system incorporating the benefits of Daikyo CZ as an alternative to glass for biotech products," stated Mr. Norton.
In May, West announced the first customer-sponsored clinical trial for the SmartDose system incorporating the Daikyo CZ cartridge. West is also working closely with several pharmaceutical companies that have expressed interest in the SmartDose system and are currently performing drug stability studies in the Daikyo CZ cartridge.
"The SmartDose system with Daikyo CZ cartridge is an excellent example of West's partnership with biotech companies to offer fully integrated drug delivery systems designed around the importance of understanding patient needs, protein drug requirements, the primary container and an effective delivery system," said Mr. Norton.
The Daikyo CZ cartridge with the Flurotec® film coated piston and seal comprise a container system specifically designed for the needs of most modern biologic medications. West and its partner Daikyo Seiko, Ltd. have developed CZ primary container systems to reduce interaction with biologics, and to realize the added benefits of break resistance, higher standards of quality, dimensional tolerance and functionality that are associated with polymer systems.
West believes that the study results will be useful to its pharmaceutical and biotechnology customers as they partner with West on the SmartDose technology.
West works side-by-side with its healthcare partners from concept to the patient, designing and manufacturing packaging, diagnostic and delivery systems that promote the efficiency, reliability and safety of their products. Every day, West is leading the way with cutting-edge technologies and quality systems, a thorough understanding of global regulatory compliance, and an unmatched and growing knowledge base of relevant pharmaceutical product testing, development and packaging. Based in Exton, Pa., West supports its customers from sales, manufacturing, customer support and research and development locations in North and South America, Europe, Asia and Australia. Established in 1923, West's 2012 sales were $1.3 billion.
The SmartDose patch injector is for investigational use only by our pharmaceutical and biotechnology development partners. West seeks partners for the SmartDose technology platform. This platform is intended to be used as an integrated system with drug filling and final assembly completed by the pharmaceutical company.
West and the diamond logo, and By your side for a healthier world™ are registered trademarks or trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. SmartDose® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Daikyo Crystal Zenith® and Flurotec® are registered trademarks of Daikyo Seiko, Ltd.
Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
SOURCE West Pharmaceutical Services, Inc.