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Cell-based therapies are a unique solution to a variety of health issues, and can make an undeniable impact on a person’s life. But with this unique solution comes several challenges, including packaging issues associated with cryogenic storage, inspection, and extraction of the drug product. Selecting the right packaging for the cell line can mitigate risks of breakage and cell death, enhance your ability to conduct crucial stability and integrity testing, and enable ease of transition during each phase of development.
Cell lines require low temperature storage. Many packaging systems are made of glass, which can’t handle the challenges of cryogenic storage, nor can glass systems maintain seal integrity at such low temperatures. Issues like breaking and cracking when the vials are dropped or brought to room temperature can lead to cell death. In addition, many cryovials are not transparent, making visual inspection of the vials difficult. Finally, extracting the cell line with a needle can damage or shear the cells.
By tackling packaging challenges early in development with a market-ready system designed to withstand the rigors of cryogenic freezing and thawing, pharmaceutical manufacturers can save time and effort, and help smooth the path from research and development to commercialization.
Use of a cyclic olefin polymer vial, like the Daikyo Crystal Zenith® vial, can help mitigate the risks associated with cryogenic storage. Daikyo Crystal Zenith vials are made from a break-resistant cyclic olefin polymer that has excellent thermal characteristics and can withstand cryogenic temperatures as well as sterilization by autoclave. These vials have been shown to successfully maintain container closure integrity at -165 °C after eight days of storage. In addition, needle-free vented vial adapters can help reduce the impact of shear and cell rupturing when extracting from vials.
The West Ready Pack® System featuring Daikyo Crystal Zenith vials, FluroTec® stoppers, seals and vial adapters can help you get through the next phase of your development. Ready Pack can be ordered in small quantities during research and development, and when you’re ready to go to market, scale-up is simple and there’s no need to change packaging.
For more information about Crystal Zenith or the Ready Pack system, click here or contact Technical Customer Support today.
Container systems must protect parenteral drug products through the entire shelf life. To accomplish this, container components (vial, elastomer stopper, and metal seal) must fit together well, and maintain an impervious seal. In a sealed system, elastomers are under compression, and it is well known that under compression they undergo relaxation. This raises the question whether such relaxation will affect the seal performance over time, and thus container closure integrity (CCI).
<p><strong>Part I</strong></p><p><em>This is a first in a two part series dedicated to the origins and attributes of the Daikyo Crystal Zenith® Polymer </em></p><p>In the early 1990s, Masamichi Sudo, founder and past president of Daikyo Seiko, Ltd., first developed the Daikyo Crystal Zenith polymer. This custom formulated cyclic olefenic polymer, available today in the Daikyo Crystal Zenith (CZ) portfolio of products offered by West, represents his lifelong ambition to improve all aspects of parenteral packaging and commitment to delivering the most precise formulation to the marketplace.</p>
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
On March 25, 2017, West team members participated in the Girls Exploring Tomorrow’s Technology (GETT) Expo, a STEM career exploration event for girls in Grades 5 - 10. West sponsored the event which took place at West Chester East High School in West Chester, Pennsylvania. Employees representing a variety of functions within the business helped to staff the booth.<br />
<p>West is thrilled to announce that Lisa Bakazias, VP, Operations, Manufacturing Strategy, was recently named as our 2018 HBA Luminary.</p>
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