Author Archives: Steven Le

Rapid Identification of Stable Biologic Candidates During Cell Line Development

There’s no doubt that CHO cell lines are being pushed to their limits: Newer and more complex biologic modalities have low expression yield Dramatically higher concentration requirements of injectables Larger market demands with increasing awareness of new biologics based therapies. While advancements are being made, little has been done to characterize the physical stability of secreted antibodies from their inception during CHO cell line development. Scientists have been forced to stabilize biologics that were not designed with aggregation in mind…

Small Samples, Big Discoveries: Characterizing AAV Aggregates at Low Volumes and Identifying Their Root Causes

Gene therapies that use AAVs have shown great promise, but can be unstable due to their fragile composite DNA/protein nature, which presents an analytical challenge when determining root cause of subvisible particle (SVP) formation and product instability. Understanding how these proteins interact with leaked payloads will allow better insight into avoiding aggregate buildup. Yet, this has been difficult, hampered by legacy systems that cannot conduct low volume SVP analysis or interrogate for DNA content. That’s about to change. In one…

Get High-Throughput, Definitive Identification of Viable Cells and More in Your Cell Therapy

Analyzing for viable cells using traditional methods such as flow cytometry often encounters clogging resulting in the loss of precious cell therapy samples. Not only is it low throughput, but incredibly complicated, which can lead researchers to misidentify cellular and non-cellular material and confuse cell viability results with product-purity issues. Additionally, it is a regulatory requirement for all injectable drug products be characterized for sub visible particles (SVP) and aggregates that may form during a manufacturing process. With Backgrounded Membrane…