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Subvisible Particle ID in Cell and Gene Therapy with the Aura CL
Wednesday, May 19, 2021 8:00 am – 9:00 am (PDT)
Detecting subvisible particles in cell and gene therapies is difficult because historic methods use prohibitively large volumes and the therapy itself is often a particle of similar size to the undesirable subvisible particles that can contaminate the product. Many methods have been attempted to discriminate cell vs non-cell or capsid vs non-capsid particles including machine learning and manual image inspections, but these techniques use unreliable morphological characteristics and often fail to properly classify the particle type.
Introducing the Aura CL, the first subvisible particle detection platform specifically designed for cell and gene therapy applications. In as little as 5 µL, the Aura CL can quantify subvisible particles and ID them as cellular, protein, viral capsid, or extrinsic material in a matter of minutes. The Aura CL uses a direct and specific fluorescent labeling approach so there is no need to rely on inaccurate morphological characteristics. Based on USP 788, the Aura CL is easy to validate and incorporate into all particle testing workflows.