Experimental Cellular Therapeutics Laboratory

The mission of the ECTL is to help St. Jude investigators develop clinical grade manufacturing processes in close collaboration with the St. Jude GMP facility. The Laboratory is focused primarily on:

• Developing processes and providing services for the clinical scale purification, engineering, genetic modification, expansion, and cryopreservation of cells for manufacturing cellular products
• Generating relevant data, preparing documents to support Investigational New Drug (IND) applications to the FDA
• Developing, Identifying, introducing, and validating new technologies to facilitate and improve processes for manufacturing cellular therapeutics.

The ECTL works directly with investigators on cell and gene therapy (CGT) process and assay development and translation of CGT products to the GMP. The ECTL has five senior researchers, all have Ph.D. degrees in biological or medical sciences, and each has more than five years of productive post-degree laboratory research experience. All ECTL staff participate in the cGMP trainings organized by the quality assurance team of the TPQ, attend the weekly cell and gene therapy meetings that are also attended by clinical and laboratory-based investigators, GMP and TPQ staff, and biweekly meetings with the GMP cellular products production team. These interactions ensure effective development and transfer of the manufacturing processes for new cellular products to the CGL for manufacturing.