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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 -80oC. 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).
West’s scientists have examined this issue in detail and reported their findings in the just-published technical report: Ingress of Gases into Cyclic Olefin Polymer Vial Based Container Closure Systems at -80oC. Focus was on systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials. It was demonstrated experimentally that for either refrigeration or storage on dry ice, rate of ingress of oxygen and carbon dioxide is very low and quantifiable. Studies such as these enable customers to make proper risk assessments, and thus select the right vial containment systems.
In view of these studies, and the inherently better fracture resistance of polymers, COP-based vial containment systems are an excellent choice for many gene therapy drug products. For more, contact an Account Manager or a Technical Customer Service representative.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
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 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 />
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.
The need to provide vaccines for the SARS-CoV-2 pandemic has presented the pharmaceutical industry with unprecedented challenges. Among them are accelerated timelines for development/approval and unanticipated volumes for manufacture/delivery. Ordinarily for a new drug product, there is ample time for selecting the primary package system and establishing component availability.
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