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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.
Nurturing a culture of philanthropy and community involvement is one of the defining characteristics of West. Team members around the world take their responsibility to give back very seriously, donating considerable time and resources to help create a healthier world. West without Borders, our team member-led giving programme, has raised millions of dollars since its inception in 2004 and the initiatives in Ireland were recently recognised at the Pharma Industry Awards for Corporate Social Responsibility Programme of the Year.
West’s team members in Germany have spent the past month on charitable activities as part of the 2013 West without Borders fundraising initiative. Donations inspired volunteers to prepare lunch, snacks and desserts for their colleagues. Other activities included a raffle, various food sales and a flea market at plants in Eschweiler, Stolberg and the European Headquarters at Kiefernweg to help raise money for local children in need. This year’s motto was “Gemeinsam erfüllen wir Herzenswünsche” (Together we make dreams come true).
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has released its 4040 LyoTec® Westar® Select Ready-to-Sterilize (RS) and Ready-to-Use (RU) Lyophilization Stoppers, the first components of a portfolio of vial closures to be developed using West’s new state-of-the art elastomer formulation, 4040/40 gray. By combining the demonstrated success of an established design and significant levels of expertise in testing and raw material selection, we have achieved improvements and optimized benefits across the spectrum of packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
Mobile technology can be a great time saver, or a time-sink, depending on the apps you’re using and how you use them. At West, we recognize that it’s important to choose your apps wisely. As we begin to build our Mobile App Store, we are focused on applications that enable us to be more connected and forward-looking – foundations for being successful in a globally competitive world. Since there’s an app for almost every purpose these days, we believe that it’s critical to reduce distraction by focusing on apps that will improve productivity wherever our work takes us.
West was pleased to recently attend the U.S. FDA’s first Compounding Center of Excellence Conference “Working Together for Patient Safety” on September 21st and 22nd. The virtual conference brought together current and future outsourcing facilities, state and federal regulators, experts, trade organizations and other industry stakeholders to learn and engage on key topics and best practices.
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