Resource Library

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.

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.

Market trends to cold temperature storage, challenges this poses with traditional bottles and bags and how PTFE can help.

Growth in biologics, benefits and risks of single use bags and how GORE STA-PURE Flexible Freeze Containers can help.

Risks in the biopharmaceutical cold chain and how GORE STA-PURE Flexible Freeze Containers utilize ePTFE to address the risk.

When comparing containment systems for cold chain use, it is critical to understand all the factors that can affect performance. Although polymer bags are an excellent choice for this application, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures. A full suite of application testing is necessary to determine whether a bag will hold up to all the rigors of handling and shipping at extremely cold temperatures.