For the packaging of IMLYGIC (talimogene laherparepvec), approved by the FDA in October 2015 for the local treatment of certain lesions in patients with melanoma recurrent after initial surgery, Amgen has selected vials from West Pharmaceutical Services made from Daikyo Crystal Zenith (CZ; a cyclic olefin polymer). The CZ vials also feature West FluroTec stoppers with West’s barrier film technology.
While CZ has been used for packaging pharmaceuticals and biologics for years, its selection for IMLYGIC is “significant news” because the product is stored in “extreme cold storage at -90°C,” explains John Paproski, Senior Vice President and Chief Technology Officer, West. The lowest temperatures have most commonly been “as low as -60°C,” he says, speaking with PMP News.
Most of the challenges encountered with drugs stored at temperatures as low as -90°C involve “container closure performance,” he says. “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.”
Paproski says it is easier to hold dimensional tolerances with CZ versus glass. “Flange consistency in terms of size and dimension is more consistent with plastic than with glass. With glass, it is challenging to hold tight tolerances,” he says. When it comes to CZ, “Daikyo has developed decades of molding techniques, such as how you gate the polymer and how it cools.” (West and Daikyo have worked together since the late 1970s, building a portfolio of options for vials, prefillable syringes, and other systems).
“We are applying new technologies and a more practical approach to demonstrate that container closure integrity is maintained with CZ,” he says. The FluroTec stopper that is part of the CZ vial system helps with the extractable and leachable profile.
Paproski says that CZ will continue to serve the industry in traditional vial formats as well as in prefilled syringes and other drug-delivery devices. “Cyclic olefin polymers provide an important contribution to the industry,” he says. “With some of the drug delivery systems in development, we need the design flexibility CZ has to offer—allowing new shapes to deliver larger volumes of potentially more viscous drug products.”
Says Bill Rich, Vice President, Device Technologies at Amgen, in a news release: “We appreciate the relationship we have with West and how they have worked with us to provide an appropriate container closure solution to address the ultra-cold storage conditions for IMLYGIC.”
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