Newsletter | September 20, 2021

09.20.21 -- Cell & Gene Therapy Freezing Requirements Change Single-Use Paradigms

 

Vendor Partnering In A Bioprocess Manufacturing And Supply Chain Ecosystem

As novel therapies produced and stored under extreme conditions become more common, containers that were adopted decades ago are increasingly unable to meet project needs and regulatory standards. New single-layer assemblies, made with more robust materials and without the curing agents, antioxidants, plasticizers, or adhesives that represent potential contamination sources, may offer companies a safer, more efficient choice.

Solutions For Single-Use Bag Assemblies
Aramus Single-Use Bag Assemblies For Cryogenic Temperature Compatibility
 

This application note explores the cryogenic temperature compatibility of the Aramus bag assembly material through freezing and drop testing after 24-hour minimum immersion in the liquid nitrogen (LN2) vapor phase.

Shorten The Seed Train With High-Density Cell Banking
 

The current process of growing production-level biological cultures from a single cell sample has two major difficulties: It takes a long time and it includes many opportunities for contamination. Entegris can help with Aramus single-use fluoropolymer bags. Here’s how.

Aramus Single-Use Bags Compatibility With Dimethyl Sulfoxide (DMSO)
 

This application note reviews the chemical compatibility of Aramus assemblies with dimethyl sulfoxide (DMSO), which is commonly used as a cryopreservant in the cell and gene therapy (CGT) markets.

Aramus Single-Use Bag Particle Testing: Particle Count Testing To Assure Surface Cleanliness
 

Cleanliness of parts or enclosures is important to avoid the presence of particulate contamination that can be detrimental to quality or performance. An accepted approach to determine cleanliness is the use of liquid particle counters to quantify size and count of particles in water after exposure to the part of interest.