Author Archives: Dominic Clarke, PhD

Freeze-Pak™ STS Bio-Containers and STS Shippers: A New Single-Use Solution for Frozen Storage & Transport to -80°C

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Frozen storage is commonly performed and enables manufacturing process flexibility, long-term product stability and minimizes logistics challenges.  While single-use containers are available for storage and transport of frozen products, some require a significant investment while others don’t offer the necessary support and protection. Using films and bags not designed for frozen storage applications can be detrimental.   Charter Medical recently developed a new family of single-use frozen storage and transport solutions. The Freeze-Pakâ„¢ STS (FP-STS) bio-containers and supporting secondary single-use…

November 10, 2014

Freeze-Pak™ STS Biocontainers and STS Shippers: Offering a New Single-Use Solution for Frozen Storage and Transport to -80 °C

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Frozen storage is commonly achieved using single-use containers that enable manufacturing process flexibility and long-term product stability as well as minimize logistics challenges. Single-use containers also are available for storing and transporting frozen products although some require a significant investment, and others don’t offer necessary support and protection. Charter Medical recently developed a single-use frozen storage and transport shipping solution designed to complement single-use Freeze-Pakâ„¢ STS (FP-STS) biocontainers, which are engineered specifically for frozen storage applications. The bags and shippers…

August 15, 2014

Validation of the New Single-Use Freeze-Pakâ„¢STS

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Figure 1:  Production of biologics — whether for clinical development or large-scale manufacturing campaigns intended to be converted to final drug product — often involves frozen storage. It provides manufacturing process flexibility while enabling long-term product stability. Products are frozen and stored using a number of technologies: stainless-steel vessels, bottles, carboys, and disposable bags. Although single-use freezing bags are a common choice for storing biologics, challenges with durability persist. Single-use bags intended for freezing and storage are often made with…

August 1, 2013

Single-Use Technologies in Cell Therapy

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Single-use technologies (SUTs) are tools that can be used in producing cell therapies and personalized medicines. Such products must meet specific requirements because of the way they are used. To meet those criteria, the cell therapy industry simply has no alternatives to single-use systems. SUT applications are rapidly changing. Traditional uses for single-use systems in cell therapy include processing in clinical settings (e.g., blood bags, transfer sets) and research and development (e.g., T-flasks, pipettes). Although such applications continue, the commercialization…

March 1, 2013