Identify and Characterize Cellular versus Non-cellular Aggregates in Your Cell Therapy

Subvisible particles (SVPs) in your cell therapy can negatively impact product efficacy, safety, and stability and therefore must be monitored during drug development and manufacturing. Cell-based therapeutics typically do not undergo a final filtration step like biologic products, making it even more important for suppliers to consider the risks of particulates that form due to cell lysis, protein degradation, and contamination from the manufacturing process.¹ The impact of a particle will differ depending on its properties and whether it is endocytosed by the cell or alters the cell environment. Thus, accurately identifying the SVP source is critical when putting mitigation steps into place. But how do you monitor aggregates when cells themselves are subvisible in nature? 

Aura CL™ uses Fluorescent Membrane Microscopy (FMM) to tell you exactly if your aggregate is cellular or non-cellular in your sample. It overcomes the challenges faced by fluidic imaging cytometry techniques, which struggle to differentiate cell aggregates from other subvisible particles because they rely only on unreliable morphology characteristics and can miss particles due to the inherent low refractive index contrast of particles in liquid matrices. Aura CL delivers accurate cellular particle count and characterization for product quality measurements during cell therapy development and cell line development so you can develop the best therapeutic.