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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 -180oC). A challenge is selecting the right container system.
Glass systems cannot perform reliably at these temperatures – having the potential to fracture and lose container closure integrity. Polypropylene (PP) systems can perform well at these temperatures – but they are opaque, which prevents visual inspection. At the International Society for Cell Therapies Annual Meeting, Montreal, Dr. Alex Lyness, Manager, Research & Technology, addressed this in a poster entitled: Evaluation of a Novel Cyclic Olefin Polymer Container System for the Cryopreservation of Adherent and Suspension Human Cell Types.
The performance of container systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials was evaluated. Not only are COP vials break-resistant and completely transparent, this research demonstrated that COP vials enabled recovery of two different cell types (bone marrow and umbilical cord-derived) equal to PP systems. Further research is ongoing.
To learn more about Daikyo Crystal Zenith® packaging systems for cryogenic storage, contact your Technical Customer Service (TCS) representative, or visit the West Knowledge Center.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
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.
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.
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration<sup>(1)</sup>. This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
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.
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