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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.
Read the full press release here
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.
Daikyo Crystal Zenith® and Flurotec® are registered trademarks of Daikyo Seiko, Ltd.
Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.