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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.
The advantages include:
And because coefficients of thermal expansion match more closely between rubber/polymer than between rubber/glass, there is lower risk of loss of container closure integrity (CCI) at cryogenic temperatures. In view of the advantages of polymers, the obvious question concerns the best polymer. The requirements are:
These points were considered in detail in the presentation: "Challenges in Low-Temperature Storage of Cell Therapy Drug Products at PepTalk 2020." Considered also were the O2 and CO2 permeability rates of COP-based containment systems, from room temperature down to -80oC and -180oC. Rates were for the first time quantified; and they were demonstrated in fact to be low. Moreover, these systems demonstrated excellent CCI down to -180oC. These data indicate that COP-based systems should be suitable for a wide range of drug products stored at cryogenic temperatures. For more, 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.
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.
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).
Gene therapies are stored and shipped at ultra-low temperature (approximately -80<sup>o</sup>C, either in a refrigerator or on dry ice). This provides a challenge to the primary package systems in maintaining container closure integrity (CCI), especially systems comprising glass vials and elastomer stoppers. These materials have different coefficients of thermal expansion. Upon cooling from room temperature to ultra-low temperature, they contract at different rates; this may lead to gaps and CCI loss.
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.
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