In biopharmaceutical production, each instance where materials or products in development must be stored, handled, or transported presents a risk for breakage, contamination, and expensive product loss. In a modern, decentralized biopharmaceutical production line, materials and products must be kept frozen to ensure product safety, consistency, and shelf life. Because of these new realities, we face more production costs, logistics, speed, and complexity.
Bioproduction today has dramatically increased the value of product in each container. Production processes have been contracted out or may be taking place in different parts of the country or globe. At colder temperatures, containers have considerable limitations; traditional storage bottles are often more brittle at cold temperatures and can break easily, do not pack into containers or store in freezers efficiently and take longer to freeze and thaw due to their shape and volume.
Entegris is in a unique position to help overcome these cold temperature challenges by offering assemblies designed for extreme cold and by partnering with qualified equipment manufacturers specializing in reliable, cold-chain containment. Let us help you gain control over your processes and reduce the potentially enormous financial risk to your valuable products.
Low Risk Frozen Distribution Of Single-Use Bags For Bioprocessing
This paper will discuss the results of applying an approach using sensors and more suitable material to a frozen shipping study of single-use fluoropolymer bags.
Particle Size Analysis Overview
This paper reviews different analytical techniques for particle size analysis, including types of distributions, laboratory versus online systems, and sample result comparisons. It is intended to help those new to particle size analysis understand each technique’s various strengths and weaknesses in order to select the proper technique for their samples.
Subvisible Particulate Matter Testing
This application note demonstrates the capabilty of advanced, automated systems for subvisible particle testing in injections, ophthalmic solutions, and lipid emulsions.
Single-Use Fluoropolymer Bags For Efficient High-Density Cell Banking
This paper explains how single-use bags perform during freezing, storage, and thawing steps and why they present an efficient alternative to vials in a variety of upstream cell banking applications.
Advantages Of Single-Layer Film Vs. Multilayer Film In Bioprocessing
Speed and flexibility are critical to succeed in the bioprocessing market. Plastics technology enables small-batch, single-use packaging solutions for customized drugs to serve a smaller patient population.
Single-Use Technology In Frozen Bulk Drug Storage: The Cold Hard Facts
This paper addresses the challenges of bulk drug substance storage, shipping, and other factors users must consider in deciding whether and how they will adopt the technology.
Cold-Chain Bioprocessing: Mitigate Risk, Protect Biopharma Products
Many mAbs, vaccines, and other biotherapeutics must be reliably stored and transported at sub-zero temperatures, requiring a robust cold chain that continues throughout downstream processing.
Risk Mitigation For Single-Use Cold Chain Distribution
In this recorded webinar, we will share risk mitigation study data showing the utility of low temperature suitable materials and packaging, employment of sensors for monitoring shipments, and better qualification and evaluation through simulated standards and real-world transit.
High-Density Cell Banking
How high-density cell banking accelerates upstream processes by providing a larger volume of concentrated cells at the start of a production run, shortening seed training from weeks to days.
Low-Temperature Solutions For Bioprocess Applications
Explore the needs and requirements of equipment and processes to handle lower temperatures, incuding a complete, cold-resistant solution of bags, tubing, connectors, and shells for freeze/ship/thaw processes.
Cold temperature Performance: Aramus™ Film vs. Polyethylene And Polyolefin Film
This video shows examples of the performance of Aramus™ film, polyethylene, and polyolefin film when subjected to cold temperatures.
Cold Resistance: Reduce Your Low-Temp Bioprocessing Risks
Janelle Rupkalvis from Entegris Life Sciences describes the options, technologies and suppliers for single use assemblies in low temp bioprocessing.
Rapid Turnaround For Customer Orders
Janelle Rupkalvis describes the process and options for ordering single use assemblies from Entegris Life Science.
Single Use Technologies For BDS Freeze/Ship/Thaw
Mike Johnson, Johannes Kirchmair (SUS) explains the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells.