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This chapter discusses basics of gene therapies, including function, anticipated growth rates, companies involved and estimates of therapies in pipeline, commercial products and indications, and the need for ultra-low temperature storage and compatible vial containment systems.
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This chapter explores how vials comprising Daikyo Crystal Zenith® cyclic olefin polymer and elastomer stoppers with a FluroTec™ barrier film to provide better protection than corresponding borosilicate glass vials and elastomer stoppers without a FluroTec barrier film.
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Storage of a vial containment system at ultra-low temperature (approx. -80°C) presents risk not encountered at ambient temperature. Review material advantages of Daikyo Crystal Zenith® cyclic olefin polymer vials along with a discussion of risks from over-filling and improper assembly.
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Systems comprising Daikyo Crystal Zenith® cyclic olefin polymer vials and elastomer stoppers with a FluroTec™ barrier film were evaluated over time in a: (a) refrigerator at -80°C, and (b) dry ice container (-78°C). Excellent performance was observed, and no sample was breached.
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Vial containment systems were evaluated for maintenance of virus transducability after storage at ultralow temperature. With selected lentivirus vectors, adenovirus vectors, and AAV vectors, all vectors showed equivalent or better function compared to standard systems.
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Proactively understanding containment system performance, especially at demanding conditions, can streamline development and accelerate market delivery. Comparative data indicates that CZ-based systems meet or exceed the performance of traditional glass or polypropylene options.
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Meet West at ISCT in New Orleans May 7 - 9 to learn more about our Cell and Gene capabilities. Come see us in booth 428. Schedule a meeting.
West will also be at ASGCT in New Orleans May 13 - 16 in booth 1358. Schedule a meeting.
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