Cell Therapy – Product Purity

CAR-T and other cell therapies have advanced personalized medicine to improve cancer patient outcomes. However, cell therapy developers face several challenges when monitoring subvisible particles (SVPs) to ensure product safety and efficacy. Flow cytometry methods are too low-throughput while methods like light obscuration (LO) and flow imaging (FI) are approximately 60% and 50% accurate, respectively, when cells clump or are out-of-focus.¹ Additionally, distinguishing cells from other SVPs is difficult because cells themselves are subvisible in nature.

Aura CL™ and Aura+™ are fluidic-free subvisible particle analysis systems that utilize Backgrounded Membrane Imaging (BMI) and Fluorescent Membrane Microscopy (FMM) to ensure accurate count, size, and morphology data and definitively discriminate between cellular, non-cellular, and non-biological contaminants like residual Dynabeads™ in your cell therapy.