Protect and Preserve Product in Freeze/Thaw, Storage, and Shipment
The cell and gene therapy (C>) fields of biomedical research have similar goals targeting DNA or RNA inside or outside the body by modifying genetic material to improve functioning or to fight disease. Cell therapy introduces new cells into a patient’s body to grow, replace, or repair damaged tissue to treat a disease. In gene therapy, genes are modified or incorporated into a patient’s body to treat, prevent, or potentially cure a disease. A therapeutic gene can be directly delivered to cells inside the patient’s body or inserted into cells outside the body before being introduced into the body.
Many C> treatments such as CAR-T and mRNA vaccines require repeated freezing and thawing during production, storage, and delivery. Aramus™ single-use assemblies are ideal for protecting and optimizing the cold-chain freeze/thaw processes for these precious treatments.
Through our 2D bag material selection, designs, and secondary protective shells, Aramus assemblies can substantially reduce the risks associated with cell and gene therapy storage and transport.
Cell and Gene Therapy Scale-Up Considerations
Rapid Scale-Up of Cold-Chain Operations in Drug Development and Manufacturing
This paper discusses the cold-chain supply scale-up challenges that can threaten product integrity during freeze/thaw, storage, and shipping, and the importance of empowering manufacturers to implement efficient, cost-effective solutions.
Accelerating Cell and Gene Therapy Development
This report created by Pharma IQ produced in collaboration with Entegris draws on the insights and experience of industry professionals from organizations the likes of Entegris, AstraZeneca and PPD. It outlines the challenges that prevent the acceleration of CGT development, including manufacturing and scaling, and offer solutions for overcoming them.
Optimize DNA Storage Using Dedicated Fluoropolymer Film for Cell and Gene Therapy Products Development and Manufacture
In this webinar, Julien and Mark will examine the advantages of fluoropolymer film as material of choice for the storage and development of high value oligonucleotide-based payloads such as an ssDNA aptamer.
Global Engage Webinar: Biomanufacturing with Fluoropolymer Single-Use Systems
In this webinar, Julien Muzard, Field Applications Technologist, will discuss recent biocompatibility data obtained using our gamma-stable, fluoropolymer platform and its advantage in a modern manufacturing environment for handling almost any biological fluid.
Single-Use Material Selection for Critical Storage Operations in Gene Therapy Development and Scale-Up
This webinar will provide guidance for manufacturing and process professionals around key product contact material requirements, storage and cryogenic process compatibility and material selection.
Single-Use AAV Bioprocess Applications
GEN Interview | A Case Study Designed to Optimize AAV Process Development and Tool Selection
Entegris scientist Joy Xiaohui Chen, PhD, discusses a case study that concluded using single-use fluoropolymer bags can help avoid or minimize product loss during adeno-associated virus (AAV) manufacturing processes.
A Material Characterization Study for AAV Process Development and Tool Selection
This webinar will walk through a case study evaluating single-use bag material interaction and adsorptive relationship with adeno-associated virus (AAV) viral vectors during storage. It will provide a review of the experimental methods, analytical approach, and results.
On Demand Webinar
Particulate Contamination in Medical Devices and Single-Use Systems
- The importance of subvisible particulate testing of medical devices and single-use systems
- Why and how subvisible particulate testing of medical devices is performed using the single particle optical sizing (SPOS) technique
- Detailed results from infusion sets and enteral bags
- Particulate testing for Entegris single-use systems (SUS), including Aramus® bag assemblies
- Internal particulate testing protocol and results comparing Entegris with competitors' products
Application NoteLife Sciences
This application note explores the growing purity needs in single-use systems used in pharmaceutical and biopharmaceutical industries, and analyzes particulate contamination levels in Aramus™ bag assemblies using the AccuSizer® SPOS system.
Impact of Scalable Freeze/Thaw Cycling on Protein Stability and Structure
In this webinar we will review key requirements and considerations for the freezing of bulk drug substances or APIs, examine the properties required of a 50 mL to 50 L scalable system and evaluate a model protein stability study to determine optimal freeze/thaw solutions.
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.