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 for Low-Temperature Applications
View this video in which Janelle Rupkalvis, Entegris 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
Featured White Paper
Cold-chain Bioprocessing Readiness: Mitigating Risk and Protecting Pharmaceutical Products
This white paper addresses the concerns of development laboratories, contract manufacturing organizations (CMOs), and contract research organizations (CROs) and explains several factors they should consider when expanding operations and selecting single-use systems for cold-chain bioprocessing.
Featured Pictogram
Switching to Single-Use, Single-Layer Fluoropolymers for Bioprocessing
This pictogram illustrates the positive impact switching to single-use, single-layer fluoropolymers for bioprocessing can have on maintaining product safety, consistency, and shelf life at cold temperatures.
Featured Webinar
Low-Temperature Solutions for Bioprocess Applications
In this recorded webinar, Janelle Rupkalvis, applications engineer for Entegris and Alex Kakad, product marketing manager for Advantapure/New Age Industries discuss the needs and changing requirements of standard equipment and processes to handle lower temperatures.
Cold Resistance Solutions
Janelle Rupkalvis, Life Sciences applications engineer, explains the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells to protect frozen BDS and reduce your risk during shipment and storage. Runtime: 03:50
Avoid stability and quality concerns with Aramus™ Assemblies
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Protect your high-value fluids with reduced risk of product loss, contamination or compromised quality
- High-grade, gamma-stable fluoropolymer
- New single-layer technology, and no binders, agents or adhesives
- Durable in frozen applications (to -85°C [-121°F] or lower)
- Universal material compatibility
Learn more about the Aramus™ 2D Single-Use Bag Assembly.