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Gene therapies are stored and shipped at ultra-low temperature (approximately -80oC, 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.
Polymers have coefficients of thermal expansion closer to those of elastomers. Thus systems comprising polymer vials, in particular Daikyo Crystal Zenith® cyclic olefin polymer (COP), have a lower risk of CCI loss. This was discussed in a recent report by West scientists: Ingress of Gases into Cyclic Olefin Polymer Vial-Based Container Closure Systems at -80 °C. It was demonstrated that at ultra-low temperatures, COP systems provided excellent CCI; in fact permeability to oxygen was comparable to that for glass systems.
Stored on dry ice, there was only a very small transmission of carbon dioxide (the case for all polymers). After 3 days (typical for shipment) and subsequent warming, rate of carbon dioxide ingress was only 0.01% per hour. Use of a secondary container (heat-sealed polyester bag) prevented ingress altogether.
Considering the other features of COP systems, i.e., low extractables, lack of interaction with drug products, and resistance to breakage, it is clear they can be an excellent choice for gene therapies. West offers COP vials in a variety of sizes with matching components, in particular NovaPure® stoppers and Flip-Off CCS® seals, for a complete containment system. For more information, contact an Account Manager or Technical Customer Support representative.
Flip-Off CCS® and NovaPure® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Crystal Zenith® is a registered trademark of Daikyo Seiko Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
West will be exhibiting at the Partnership Opportunities in Drug Delivery (PODD) Conference on October 14-15, 2014 at the Renaissance Boston Waterfront Hotel. West’s Zach Marks will be presenting an overview of the SmartDose® electronic wearable injector.
At West, we are committed to safeguarding the health and safety of the millions of patients who use our products every day. This commitment is anchored in our Core Value of Leadership in Quality, which ensures we never compromise on quality because we know that patients are counting on us.
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.
Don’t miss an opportunity to meet with West experts at an upcoming tradeshow! Stop by our booth or one of our presentations to learn more about how West can help address common industry challenges with drug product packaging and delivery.
Diane Paskiet, Director, Scientific Affairs, serves as co-chair for the 2014 PDA Packaging Conference: Pharmaceutical Packaging Systems – <em>Current and Emerging Practices, Technologies and Materials</em>, which will be held at the Washington Marriott Wardman Park, Washington, D.C. on May 20-21, 2014.
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