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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.
For the pharmaceutical industry, the cost of developing new and innovative therapies will continue to rise (the cost of developing a drug is now estimated to be between $1.5 billion to more than $1.8 billion<sup>1</sup>).
As advancements in pharmaceutical technology increase in the use of automated injection systems for health care treatment, traditional glass vials, syringes and cartridges must withstand higher automated delivery forces and pressures. The fragile nature and dimensional variability in wall thickness of glass components may lead to breakage, which presents challenges to automatic administration systems.
When combined with the industry trends of increased regulatory scrutiny and higher focus on patient safety, risk management, and compliance, the market is seeing an increased need for high-quality drug delivery systems such as prefillable syringes.
Fran DeGrazio, Vice President, Global R&D, TCS and SPM, Pharmaceutical Packaging Systems, recently contributed a chapter on primary container components to <em>Quality by Design for Biopharmaceutical Drug Product Development</em>. The volume, which was released in April 2015, is the first comprehensive overview of QbD as it applies to nearly every aspect of biopharmaceutical development.
One of the main risks associated with drug delivery via vial containment systems is particles that can result from fragmentation and coring of rubber stoppers subjected to needle or spike punctures. This risk can be mitigated by using prefilled syringe systems, whereby the drug dosage has been filled into the syringe by the drug manufacturer. The drug dosage is then administered by subcutaneous or intramuscular injection. A prefilled syringe system generates fewer particles during drug administration, as compared to a vial containment system. Furthermore, this form of drug delivery system ensures efficiency and greater convenience.
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