Years of research and innovation within the cell and gene therapy space are rapidly showing signs of success, as an ever-increasing list of therapeutics have either already been approved for clinical use or are set to burst on the scene. Biomanufacturers have developed cutting-edge processes to create these life-saving compounds. Still, safety is always a paramount concern, and companies are constantly looking for new ways to improve their product and pipelines. Subvisible particle contamination is the leading cause of drug product recalls and a critical quality attribute, and improved modalities to easily detect and identify these particles are crucial.
In some of the newest cell and gene therapies, the drug itself is subvisible in nature. So, how do you tell a good particle (like a cell) that should go into a patient from a harmful particle that should not? In this GEN webinar, we are going to hear about a new way to determine the good and the bad from our distinguished presenter Dr. Bernardo Cordovez. We will learn about case studies measuring stability and purity of CAR-T cell therapies and AAV gene therapy products using the Aura CL™—an instrument designed specifically to detect, count, size, and identify subvisible biological aggregates and extrinsic materials for product quality measurements in cell and gene therapy applications.