Bruce L. Levine
Built the manufacturing that turned CAR-T from a lab idea into a product given to thousands of patients.
Co-developer of the CTL019 manufacturing process and long-time leader of Penn's cell production facility; past president of the International Society for Cell & Gene Therapy.
| Title | Journal | Year |
|---|---|---|
| Global manufacturing of CAR T cell therapy | Molecular Therapy Methods & Clinical Development | 2017 |
ELIANA turned CAR-T from a single-centre experiment into a licensed product and created the regulatory and logistical template every later cell therapy has followed. For children with refractory leukaemia it offers a chance of durable remission without transplant. The trial also exposed the gaps: manufacturing failures, patients dying while waiting, and roughly half relapsing within a few years.
This paper is the proof-of-concept for a living drug: a single infusion of a patient's own engineered T cells could eradicate leukaemia that had survived chemotherapy, transplant and antibody therapy. It defined cytokine release syndrome and its antidote, tocilizumab, and revealed antigen-loss relapse. It led directly to the first approved gene-modified cell therapy three years later.