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Gene and cell therapies require cryo storage – approximately -80oC for genes, and approximately -180oC (i.e., vapor of liquid nitrogen) for cells. This requirement places a very high demand on the packaging to provide both good container closure integrity (CCI) and preservation of drug product viability.
This was discussed in detail in the recent presentation by Matthew Gehrmann (Sr. Scientist, Scientific Communications) titled Low Temperature Storage: Preservation of Cell-and Gene-Based Drug Products at 2019 PDA Biopharmaceuticals Week.
It was shown that the system comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials and West rubber stoppers provided excellent CCI. Because the coefficients of thermal expansion for COP and rubber match more closely than do those of glass and rubber, COP vials are very well suited to cryo storage. It was also shown that the same system provided for stem cell viability after storage at -180oC, by evaluation of recovery, morphology, and biomarker expression.
Types evaluated were:
West is committed to the safe and efficient delivery of drug products to patients – an aspect of which is experimental evaluation of its products under demanding conditions. For more on how West can address cryo storage needs of biologic drug products, contact an Account Manager or Technical Customer Support (TCS) representative.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
From May 13 to June 4, team members at our Exton, PA site banded together in our annual West without Borders (WWB) Giving Campaign in the hopes of making a big difference for Fox Chase Cancer Center and Suicide Awareness Voices of Education (SAVE).
The environment for developing an injectable drug device combination product (CP) is dynamic from a regulatory and technical perspective. At the center of it all are the patients and their needs. West is pleased to announce the publication of its review manuscript that provides a detailed overview of best practices for this kind of development program. It considers technical and regulatory aspects and can be used as a foundational document for drug formulators, scientists and engineers working in this area.
Join our subject matter experts in Boston for the 2013 Educational Series, “Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems.”
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.
Did you miss the free West 2013 Educational Series? Join us in 2014!
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