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Cell therapies are stored at cryogenic temperature (approximately -180oC, vapor of liquid nitrogen). By providing container closure integrity (CCI) under this condition, primary package systems based on Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials have a clear advantage over systems based on glass vials.
This was the focus of the presentation: Challenges in Low-Temperature Storage of Cell Therapy Drug Products delivered at PepTalk 2020. Glass and elastomers have different coefficients of thermal expansion. On cooling from room temperature to cryogenic temperature (a change of ~ 200oC), a glass vial and an elastomer stopper contract at different rates. This can lead to gaps and concomitant loss of CCI. There can be CCI loss for glass-based systems at cryogenic temperatures.
In contrast, COP has a coefficient of thermal expansion closer to those of elastomers; the risk of gaps is substantially reduced. Research at West has shown this to be the case. At cryogenic temperature, COP-based systems have been demonstrated to provide CCI. In progress are studies to show this good performance through two years. And CCI is not the only advantage of COP vials. They offer low extractables, lack of interaction with drug products, and resistance to breakage. Available in a variety of sizes for different fill volumes or stages of development, COP vials are clearly the right choice for cell therapies.
For more information visit the Daikyo Crystal Zenith Vials page here or contact an Account Manager or Technical Customer Support representative.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
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.
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.
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.
It is an exciting time to be in the Cell and Gene therapy industry. The astounding growth and development we have witnessed in the cell & gene therapy industry over the last decade is bringing life-changing therapies to the patients who have been so anxiously awaiting them. <br /><br />At the same time, as with any new drug class, challenges that may not have been considered during the drug development phase may suddenly show up and stand in the way of overcoming that last hurdle: Packaging and delivering your precious new molecule to the patient.
Cell therapies offer a powerful new approach to treat cancer and other serious conditions. The manufacture and supply of these therapies is complex – to address the short shelf lives of such living products, storage and shipping is done at cryogenic temperatures (liquid nitrogen, approximately -180<sup>o</sup>C). A challenge is selecting the right container system.<br />
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