Addressing Low-Temperature Bioprocess Application Challenges
In today's production of biologic products, we are facing far more cost, logistics, speed, and complexity pressures than in the past. The increasing value of products in each container requires more steps to produce, often working with difficult cells or extraction processes. Production has been contracted out or may be taking place in different parts of the country or globe and the equipment being used may not be compatible with extreme, cold temperatures, forcing compromises. It is important to recognize these limitations and to be aware of the options available to address these new challenges.
For stable storage and shipping, many biologics and bulk drug substance (BDS) products require -80°C (-112°F) or colder temperatures. At cold temperature, containers have considerable limitations; bottles are often more brittle at cold temperatures and can break easily; bottles do not pack into containers or store in freezers efficiently; bottles can take longer to freeze and thaw due to thickness/volume, to name a few.
Fortunately, Entegris is in a unique position to help you overcome these cold-temperature manufacturing challenges by offering Aramus™ single-use bag assemblies designed for extreme cold temperatures, and by partnering with qualified equipment manufacturers specializing in reliable, cold-chain containment. Let us help you gain control over your process and reduce the potentially enormous financial risk to your valuable product.
Rapid Turnaround with Janelle Rupkalvis
Rapid Turnaround for Low-Temperature Applications
Janelle Rupkalvis, Life Sciences applications engineer, walks through our quick-turn service for designing custom, single-use solutions that meet customer-specific requirements for unique, cold-temperature applications. Runtime: 02:44