Aura CL System

Aura CL System

Accurately identify, count, and characterize subvisible particle contaminants in minutes with Aura CL

Accurately identify, count, and characterize subvisible particle contaminants in minutes with Aura CL

Measuring particles in cell therapy manufacturing has always been a challenge, and the fact that the drug product itself is a particle makes it even harder.

Waters Aura CL System is the first system that, unlike traditional methods, quickly identifies and distinguishes cells from protein aggregates or harm-causing particles while providing all required cytometric capabilities—counting cells, identifying types, and measuring viability in one simple assay.

Powered by innovative technology, Waters Aura CL System is the ultimate tool to identify, count, and characterize subvisible particle contaminants introduced in cell therapy manufacturing—so you can access high-throughput insights earlier in discovery to develop cell therapies faster, smarter, and safer.

Maximize the purity, safety, and efficacy of your cell therapy with our simple-to-use Aura CL particle analyzer. Aura CL System

Specifications

Imaging Area

24.6 mm2

Optics

4x and 10 objectives

Minimum volume

5 µL (assay dependent)

Resolution

1.0 pixel/µm

Detectable size range

Range from >1 µm (ECD) to <5 mm (ECD)

BMI read time

1 minute/sample

FMM read time

30 seconds/sample

Software

Particle Vue 4.x all-in-one Software suite (image capture and analysis)

Overview

  • Detect and count residual Dynabeads. Finding and counting Dynabeads™* is easier than ever with Aura CL System. Unlike traditional methods that can be subjective, cumbersome, inaccurate, and prone to error, this powerful, fully automated tool allows you to make an accurate count at high speed.
  • ID cells/non cells. Rather than spending hours manually sorting through images or learning how to use complex machine learning libraries, Aura CL System makes it easy to precisely ID cells from non-cell aggregates right out of the box.
  • Analyze small volumes. Analyze small volumes. You only need 5 µL of sample, which allows for particle and cell characterization earlier in development.
  • Learn more with innovative technology. Using backgrounded membrane imaging (BMI) and fluorescence membrane microscopy (FMM), Aura CL System performs cell viability assays with definitive cell identification for 96 40-μL samples in under an hour.

Recommended Use: For fast, decisive, low volume particle characterization in cell therapy development and manufacturing workflows.



The first and only solution to detect and count Dynabeads

Residual Dynabeads in a final product can compromise potency, making bead analysis necessary to meet high quality standards. However, using manual hemocytometry to detect residual Dynabeads has been unreliable because it’s hard to tell the difference between beads and cells.

Waters Aura CL System uses side illumination membrane imaging (SIMI) to save time and costs by rapidly and accurately detecting residual Dynabeads with specificity and sensitivity. This one-of-a-kind automated product eliminates human errors to meet the highest quality standards of cell therapy lot release assays.


Get high-throughput, definitive identification of viable cells

High-throughput and definitive identification of viable cells is critical in cell therapy manufacturing. However, obtaining this key product-purity parameter has been a challenge as classic methods are user intensive and complicated—until now.

Aura CL System takes the guesswork out of cell viability assessments. Forget about using unreliable techniques like morphology and spectroscopy, as well as complicated machine learning libraries, to determine the composition of your sample.

Labeling the particles or groups of interest with fluorescent dyes or antibodies makes it possible to tell the difference between cell and non-cell parts and protein and non-protein parts in complex samples.


*Dynabeads refers to the magnetic beads produced by Thermo Fisher Scientific, Inc. Waters is not affiliated with Thermo Fisher Scientific, Inc., and references to Dynabeads or any other third-party trademark do not imply sponsorship, endorsement, or approval.


Resources

Documents

Documents


Frequently Asked Questions

Frequently Asked Questions

What are the criteria for CAR T-cell therapy? 

What are the criteria for CAR T-cell therapy? 

CAR T-cell therapy, a type of immunotherapy, involves genetically modifying a patient's own T cells to recognize and attack cancer cells. The criteria for CAR T-cell therapy eligibility typically include factors such as the type and stage of cancer, previous treatments received, overall health status, and specific genetic markers. Patients must undergo thorough evaluation and screening to determine their suitability for CAR T-cell therapy.


Related

Particle Vue Software simplifies drug development workflows with advanced algorithms, visualizations, and compliance-ready reporting for early-stage insights.

Accelerate biotherapeutic and therapeutic development with Aura+ System, designed for early particle characterization analysis across protein, antibody, cell and gene therapy workflows for better decisions sooner.

Accelerate and optimize gene therapy development with the Aura GT System, designed to evaluate capsid and viral vector aggregates by using just 5 µL of sample volume.

Offers and Discounts

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