An Automated, High-Throughput Approach for Stability Testing in Protein, Cell, and Gene Therapeutics

Product safety and efficacy is an integral part of conversations about the potential of cell and gene therapies, particularly when compared to traditional drug products like small molecules. The presence of visible and subvisible particles is a major indicator of product instability, which could negatively affect drug activity and raises concerns about patient safety. That is why stability testing using particle size analyzers is so crucial to the biopharmaceutical process. These instruments are needed to track the sizes and types of particulates that occur throughout the drug development and manufacturing process. They can assess the effects of factors such as UV light exposure, temperature fluctuations, ionic conditions, mechanical stress, and freeze-thaw cycles on protein, cell, and gene therapeutics.

In this GEN webinar, Dr. Karessa White will explore how the Aura platforms offer rapid screening to assess biological aggregation and extrinsic particulate contamination in protein, cell and gene therapeutics, from initial product selection to the manufacturing stage. During the webinar, you’ll learn how Aura fits into diverse biotherapeutics workflows to save time and improve product quality and safety.

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.