CRISPR-Cas9 is one of the most commonly leveraged non-viral editing tools to engineer cells for therapeutics applications. It is a nuclease-based genome editing system which has seen exponential growth in adoption for cell therapy development. To move your work from research through clinical trials and commercialization, access to GMP-grade CRISPR-Cas9 reagents that can meet your clinical needs and required regulatory standards is critical. In this presentation, we will explore the development of a GMP-grade Cas9 protein suitable for cell therapy applications. Then, we will focus on the manufacturing process controls and quality specifications needed to help ensure compliance to the appropriate regulatory standards. Finally, we will showcase its application in a T-cell workflow.

 

Learning Objectives