The ECTL helps St. Jude investigators develop manufacturing processes in collaboration with the St. Jude GMP facility.
The mission of the ECTL is to helps St. Jude investigators to develop clinical grade manufacturing processes in close collaboration with St. Jude GMP facility. We focus our efforts on the following areas:
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
IND submissions with clearance
clinical CAR T-cell products
clinical scale isolations and productions