Hello everyone. As we build our immunotherapy program in the region, I am looking to the future. I am excited about preparing for clinical trials of cell based immunotherapy trials. Of course, chimeric antigen receptor modified effector cells targeting malignancy are foremost on my mind, but as many of you know, I think we should look to broaden that scope to cell therapies for autoimmune diseases and solid organ transplant tolerance. Producing these products for clinical trials requires good manufacturing practice (GMP) capabilities. I am looking at traditional clean rooms vs "isolators" (I know of Biospherix and Sanyo systems). We would be using these systems for production of genetically modified immune effector cells (gene transfer protocols), and other cell therapies such as production of tumor vaccines, mesenchymal stromal/stem cell products, etc. An argument for these isolators over clean rooms appears to be cost and maintenance, but I want to be aware of capabilities and limitations with both systems.
Folks with experience in this area: Can you provide input?
Thanks
Doug
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