Overcome One of Cell Therapy's Biggest Challenges
If you need to make sure that your cell therapy is both safe and effective, and meets USP 1046 standards, traditional flow cytometry methods simply won't cut it.
Light obscuration (LO) and flow imaging (FI) only provide ~50-60% accuracy when cells clump or are out of focus1—not exactly a huge improvement. Plus, ancillary components throughout production must be tracked as part of the final product or removed if not applicable.
The good news? All these challenges can become a thing of the past with Aura+ and Aura CL—fluidic-free particle analyzers that utilize Backgrounded Membrane Imaging (BMI) and Fluorescent Membrane microscopy (FMM) so you can get precise measurements for cell therapy quality control.
- Wang X, Rivière I., (2016) Clinical Manufacturing of CAR T cells: Foundations of a Promising Therapy. Molecular Therapy Oncolytics. 3:16015. doi: 10.1038/mto.2016.15
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
*Dynabeads refers to the magnetic beads produced by Thermo Fisher Scientific, Inc. Halo Labs 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.
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.
Brightfield
FMM showing hidden cells within a fiber
See different types of subvisible particles that can be identified—CAR-T cells, residual Dynabeads and lysozyme protein aggregates—using Aura CL.
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
Featured products
Aura+
With the ability to support the full range of development and manufacturing applications across therapeutic approaches—including protein/antibody therapeutics, gene therapies, cell therapies, and small molecules— Aura+ packs powerful flexibility into a single particle analyzer.
Features
- 5 µL to 10 mL volume
- Particle characterization for protein, cell and gene therapeutics
- Three fluorescent channels for particle identification
- 4x and 20x magnification imaging
Aura CL
Safeguard your cell therapies from contamination with Aura CL. Our high-throughput, fluidic-free particle analysis system quickly and accurately identifies and characterizes subvisible particles, giving you peace of mind when it comes to cell therapy development and quality assessment.
Features
- Automated residual Dynabeads analysis
- Cell purity and viability characterization
- High powered magnification
- Fluidics free
