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Describes the freeze profile of the GORE® STA-PURE® Flexible Freeze Container including the freeze methodology and the impact of the carrier on freeze performance.

This document is available upon request.

Engineered from the same materials of construction as the GORE STA-PURE Flexible Freeze Container, the 50-ml Stability container assembly is designed to support testing during drug substance development.

Single-use GORE® STA-PURE® Flexible Freeze Containers are intended for handling, transport and storage of frozen bulk drug substances after freezing at -86°C (-123°F).

Due to the worldwide response to COVID-19-related R&D; increased development of novel therapeutics; and the expansion of cell and gene therapy innovations, biopharma manufacturers are seeing significant manufacturing momentum.

For many emerging cell and gene therapies, their increasing sensitivity and how that may impact stability have made their storage and transport uniquely challenging. This complexity has led to pioneering new container technologies designed for increasingly complex biologics; while the space had been historically dominated by bottles, closed multilayer bag assemblies and, more recently, single-layer fluoropolymer bags have become the more attractive choice for companies with colder storage and transport temperature requirements.

Protecting Drug Substance (DS) during cold chain handling, storage and transport.

Single-use GORE® STA-PURE® Flexible Freeze Containers are intended for handling, transport and storage of frozen bulk drug substances, particularly at freeze temperatures down to -80°C (-112°F).  

This document is available upon request.

Specially fitted disposable Hard-shell Carriers, suitable for plate or blast freezers, are available as accessories. They are designed to maximize freezer space, make handling easier and further protect tubing in the Container Assembly.

Market demands that are driving single use technologies, potential challenges this can cause and how PTFE can help.

Growth in biologics, benefits and risks of single use bags and fluoropolymers and why not all Fluoropolymers are the same.