Amgen has selected West’s Daikyo Crystal Zenith® vials with FluroTec® stoppers to contain its FDA-approved therapy IMLYGIC™ (talimogene laherparepvec).
There is growing demand in the biopharmaceutical industry for advanced drug containment systems for sophisticated biologics. Manufactured from a novel cyclic olefin polymer, Crystal Zenith vials offer a break-resistant, high-performance alternative to glass that is designed to meet the complex needs of next-generation therapeutics.
Most of the challenges encountered with drugs stored at temperatures as low as -90°C involve “container closure performance". “The rubber has to seal properly against the vial flange, which is the interface between the closure and the vial. What is different with extreme temperatures is maintaining tolerances and flange consistency within the whole system.”
Many new biologics require cold storage environments. While glass has traditionally been used to store and deliver many injectable drugs, it can be unstable in cold and cryogenic storage conditions and poses a risk of breakage with thawing. Our Daikyo Crystal Zenith vials are designed to stand up to ultra-cold and cryogenic environments and help protect the safety and integrity of complex injectable drug products. Additionally, IMLYGIC’s Crystal Zenith container closure system contains FluroTec stoppers, which provide a barrier against extractables and protect against the risk of contamination.
We are proud to work together with Amgen, and all of our biopharmaceutical and pharmaceutical customers, to provide integrated lifecycle solutions that are designed to maintain drug safety, purity and efficacy from development through to commercialization.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
FluroTec® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
