Cell Therapy Quality Control – Ensure Your Cell Therapy is Pure and Potent

Unlock confidence in your cell therapies with rapid differentiation between cellular contaminants and non-biological particles. Get detailed stats on count, size, and morphology for seamless accuracy every time.

Overcome One of Cell Therapy's Biggest Challenges

Why Use Aura to Assess Cell Therapy Product Purity?

  • Achieve accurate, fluidics-free subvisible particle analysis
  • Definitively ID cell and non-cell subvisible particles
  • Best in class Dynabeads® identification and quantitation
  • Extrinsic particle identification and characterization
  • Obtain detailed information on particles that other methods can’t deliver, including size, morphology, count, and distribution
  • Rapid analysis time of about 1 minute per sample
  • Benefit from a wide working range: measure particles from 1 μm to 5 mm with high reproducibility
  • Image particles without the interference of buffer or matrix for higher sensitivity
  • High-resolution particle images
  • USP 788 Method 2 and USP 1046 compliant
  • Maintain compliance with the option for 21 CFR Part 11 software


Zoom in on Particles of Interest with High Magnification Imaging

It can be hard to tell the difference between particles with similar shapes, especially if they are not labeled in your sample. Now, you can use a combination of brightfield imaging and FMM to keep an eye on extrinsic process contaminants like fibers and make sure that their concentration won't affect the safety or effectiveness of the product.

Need an even closer look? Because it uses a 20x objective, Aura+ provides additional morphological data about particles in your sample, so you can more clearly determine product purity during cell therapy quality control.

Make FMM Your Go-To Tool for Distinguishing Subvisible Particles

Both Aura+ and Aura CL use fluorescence signatures via FMM instead of morphology for identification, making cell therapy quality control simpler than ever.

Add to that Side Illumination Membrane Imaging (SIMI), which picks up non-biological and inorganic particles hidden in samples, allowing you to quickly distinguish even more types of subvisible particles without complex machine learning algorithms.

Detect Dynabeads with SIMI for Safer Drugs

Flow cytometry might seem like an obvious choice for cell therapy quality control, but it often falls short. Sample prep can be a challenge, and clogging caused by Dynabeads and cells renders it obsolete.

This is where SIMI provides a much-needed solution. Using side-illumination, it can accurately detect non-biological objects at the membrane level, such as Dynabeads, which must be identified and removed before use in cell therapies.

To make this process more efficient, Aura CL and Aura+ offer an automated way to count Dynabeads in highly cell concentrated solutions, making it possible to deliver reliable and error-free results with greater accuracy and throughput

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