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Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.
Glass and rubber have substantially different coefficients of thermal expansion (CTE), i.e., as temperature decreases, they shrink at different rates. This can lead to the formation of gaps in the glass-rubber seal and concomitant loss of CCI. This phenomenon has been well documented in the literature.
An approach to the challenge of low temperature storage is the use of polymer-based vials, such as those comprising of Daikyo Crystal Zenith® cyclic olefin polymer (COP). Having a CTE much closer to that of rubber, the risk of gap formation and loss of CCI with a COP-based vial is far reduced.
West, through the Integrated Solutions platform, has the expertise and facility to evaluate CCI of vial systems from room temperature down to -180oC – using the deterministic methods called out in USP <1207> (Package Integrity Evaluation – Sterile Products), such as tracer gas leak detection (with helium), and frequency modulated spectroscopy head-space analysis (with oxygen and carbon dioxide). This support enables customers to select the components and sealing parameters needed to protect their drug products, to help ensure safe delivery to patients.
For more on West, contact an Account Manager or Technical Customer Service (TCS) representative.Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
Cell therapies are stored at cryogenic temperature (approximately -180<sup>o</sup>C, vapor of liquid nitrogen). By providing container closure integrity (CCI) under this condition, primary package systems based on Daikyo Crystal Zenith<sup>®</sup> cyclic olefin polymer (COP) vials have a clear advantage over systems based on glass vials.
With the growth of gene and cell therapies, there is an increased need to characterize container closure systems (CCS) at the low temperatures experienced during their lifecycles: ultra-low (-80°C) for genes and cryogenic (-180°C) for cells. West’s Integrated Solutions platform includes the state-of-the-art container closure integrity (CCI) capabilities needed for these therapies.
Gene and cell therapies require cryo storage – approximately -80<sup>o</sup>C for genes, and approximately -180<sup>o</sup>C (i.e., vapor of liquid nitrogen) for cells. This requirement places a very high demand on the packaging to provide both good container closure integrity (CCI) and preservation of drug product viability.
Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.
Recently, there has been discussion in the industry regarding the utility of polymer-based vial containment systems for the storage and transport of gene therapy drug products, which can be performed as low as -80<sup>o</sup>C. Since it is known that all polymers are gas permeable, discussion has centered on whether polymer-based systems can sufficiently restrict ingress of oxygen (during refrigerated storage) and carbon dioxide (during transport on dry ice).
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