Dikran Khachadourian is a Field Application Scientist at Halo Labs. Dikran completed his undergraduate studies at UC San Diego, obtaining a bachelor’s degree in Biochemistry and Cell Biology. His interest in the Biological Sciences led him to pursue a master’s degree in Biology. After spending time in academia as a graduate researcher and educator, Dikran joined the Halo Labs team to apply his background to the ongoing advancements in biotechnology.
In all biological products, distinguishing aggregated API from other particle types matters for understanding the root cause of instability. Until now, subvisible particle characterization methods have been unreliable, slow, required significant sample volume, and have been difficult to use across different therapeutics. Here we present Aura, a USP 1788 compatible, low-volume, high throughput particle imaging system that can rapidly size, count, and characterize biological particles and identify them as proteins, non-proteins, cellular aggregates, or other types of molecules. In this talk, we will present 3 case studies: identifying protein aggregates and distinguishing them from degraded polysorbate components, determining subvisible particle content of AAV formulations at low volumes and gaining key insights on how DNA leakage plays a role in subvisible particle formation and product instability, and characterizing cellular therapy products including cell aggregation, viability, and product impurities including residual Dynabeads.