8 Ways That Osmolality Testing Improves Cell & Gene Therapy Process Development and Manufacturing

In gene and cell therapy, manufacturing capacity, production yields, and supply chain logistics continue to be an area of focus. The increased need for robust process control strategies requires a broad and versatile toolset. With yields as low as 20% for viral vector production, drug developers have to overcome the obstacles of poor process performance. Raw materials must undergo stringent qualification and process characterization is critical to optimize the product yield; this is accomplished with process parameters that can establish control through a workflow.

Osmolality is a measure of solute concentration and an indication of the solution’s osmotic pressure (USP, EP). It provides the concentration of any solution and has several potential applications within cell and gene therapy development and manufacturing.

Attendees will Learn the Following During this Presentation:

• What role does osmolality play in viral vector stability?
• How is osmolality testing used in viral vector UF/DF?
• What are some use cases for osmolality in cell culture monitoring & QC?
• How does osmolality keep cells stable during cryopreservation?

Related Resources

• 8 Ways Osmolality Testing Improves Cell & Gene Therapies Process Development & Manufacturing
• Resource Guide: Data and Compliance – What every lab should know
• Bioprocessing Osmometers Selection Guide
• Research Article: Osmolality is a predictor for model-based real time monitoring of concentration in protein chromatography