The ECTL helps St. Jude investigators develop manufacturing processes in collaboration with the St. Jude GMP facility.
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:
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.
It is time consuming and requires massive resources to move therapeutics from the bench side to GMP, and ECTL helps up to make this process effective and efficient.
Giedre Krenciute, Assistant Member
Dr. Zhou has 18 years of productive research experience in hematopoietic stem cell biology, 10 years of experience in gene therapy for immunodeficiencies and played a major role in developing a successful lentiviral gene therapy for XSCID, and 6 years of experience in developing GMP-compliant manufacturing processes to support Investigational New Drug submission of five CAR T-cell products for cancer and one genome-edited hematopoietic stem/progenitor cell product for sickle cell disease. Dr. Zhou has 5 years of experience in manufacturing cellular products in the GMP facility and 16 years of experience in leading research and process development teams.