Cell Viability

USP <1046> provides cell therapy manufacturing recommendations to ensure patient safety. Key regulatory parameters include requirements for the percentage of viable cells in a product as well as limits on process and particulate impurities. 

Traditionally, cell viability and apoptosis assessment have relied on flow cytometry and manual hemocytometry techniques. However, both methods are susceptible to clogging, which leads to a loss of precious sample, and are user-intensive and relatively low-throughput, introducing potential bottlenecks in the workflow. Furthermore, distinguishing between cellular and non-cellular material is incredibly complicated and fluidics-based methods can miss subvisible particles (SVPs) in the sample because there isn’t a lot of contrast between particles and aqueous solutions, both of which negatively impact data accuracy. 

All of these challenges are overcome with Aura CL™ and Aura+™, both powered by Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM). Aura systems are high-throughput – imaging samples in a 96-well plate in just a few hours. There’s also a greater contrast for protein aggregates when analyzed on a membrane compared to protein aggregates in liquid, resulting in improved measurement accuracy. Aura systems also avoid the clogging issues observed with fluidic-based particle analyzers and make it easy to ID different particles in your sample with FMM.