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. This application note explains the use of the Entegris AccuSizer^TM (formerly known as Particle Sizing System AccuSizer) liquid particle counter to qualify the cleanliness of the Entegris Aramus single use 2D bag assemblies.

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.

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.

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.

This application note demonstrates how the Nicomp Z3000 system is ideally suited for determining size and zeta potential of gold nanoparticles.

Understanding the cold chain supply scale-up challenges that can threaten product integrity — during freeze/thaw, storage, and shipping — empowers manufacturers to implement efficient, cost-effective solutions.

Liposomes are spherical engineered particles made of phospholipids used in the pharmaceutical and cosmetic industries. The size and surface charge of liposomes are important characteristics which require measurement and monitoring. Dynamic light scattering (DLS) is the most common analytical technique used for measuring the size of submicron liposomes. Single particle optical sizing (SPOS) is used to measure the size of liposomes greater than one micron. The Entegris Nicomp® DLS system and AccuSizer® SPOS system are used in laboratories around the world for the accurate measurement of the size and charge (zeta potential) of liposomes.

Nanotechnology has been referred to as potentially being the next technical revolution that could change the modern world. Perhaps the developments seen to date do not yet match this build up, but the combined investment by governments, universities, and industry is significant with global government investment exceeding $9 billion annually and growing. The United States government alone has invested over $27 billion since from 2001 – 2019.2 The global nanotechnology market has been estimated to be between $10 – 50 billion annually depending on definitions and sources.

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.

This paper 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.

This application note demonstrates the capabilty of advanced, automated systems for subvisible particle testing in injections, ophthalmic solutions, and lipid emulsions. 

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.

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.

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. 

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. 

Join Joy Xiaohui Chen, Senior Applications Engineer for Entegris and Cari Sadowski, Principal Scientist for Fujifilm Diosynth Biotechnologies in this webcast as they walk through a case study that evaluated single-use bag material interaction and adsorptive relationship with AAV viral vector during storage.

Cryogenic operations play a critical role in many processes. Join Ross Acucena, applications director, discusses single-use system design for cGMP cryogenic operations.

Study data shows the utility of low temperature suitable materials and packaging,  sensors for monitoring shipments, and qualification and evaluation through simulated standards and real-world transit.

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. 

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.

This video shows examples of the performance of Aramus™ film, polyethylene, and polyolefin film when subjected to cold temperatures.

Janelle Rupkalvis from Entegris Life Sciences describes the options, technologies and suppliers for single use assemblies in low temp bioprocessing.

Janelle Rupkalvis describes the process and options for ordering single use assemblies from Entegris Life Science.

Mike Johnson, Johannes Kirchmair (SUS)  explains the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells.