Vials perform in ultra-cold storage for new Amgen therapy
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.”
Source: Packaging Digest