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.

A comprehensive guide for validating these trays for use in your application. This document is available upon request.

GORE LYOGUARD Trays are fully enclosed, single-use, disposable containers that use a unique ePTFE membrane technology to both prevent cross contamination and fly-out, and enable the free exchange of moisture vapor during freeze-drying.

GORE LYOGUARD Freeze-Drying Trays are fully enclosed, single-use, disposable containers that use expanded polytetrafluoroethylene (ePTFE) membrane technology to contain and protect liquid or lyophilized active pharmaceutical ingredient (API) during the entire freezedrying process.

Cherish Robinson, Product Specialist with Gore's PharmBIO business, discusses the advantages and disadvantages of freeze-drying bulk drug ingredients.

Scott Ross, Product Specialist with Gore PharmBIO Products and Max Moore, Executive Director, Manufacturing and Operations at Ionis Pharmaceuticals, discuss the economic benefits of using bulk lyophilization for API products like peptides and olionucleotides over other techniques. This is part one of two articles published by Outsourced Pharma magazine.

Read the article here