Process development optimization for GMP manufacturing: a CAR-T case study

The cell and gene therapy industry is revolutionizing how we approach previously intractable diseases. The pipeline of these therapies is full of promise for durable cures, but the necessary tools, processes, and end-to-end solutions are required to bring these emerging therapies to the clinic. 

The path to commercialization can vary depending on the type of therapy being developed. However, all therapeutics go through similar milestones: starting at discovery and working towards commercial manufacturing. This article will focus on the middle of that journey with process development and clinical manufacturing. Specifically, on an oncology application with integrated aspects of gene therapy development and manufacturing. A chimeric antigen receptor T cell therapy PD journey towards GMP manufacturing will be outlined, with a focus on Cytiva’s collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto. 

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