Roberto Sessa

Background

About Roberto Sessa

My scientific background is in cancer cell biology, from focusing on the role of blood and lymphatic vasculature in cancer progression during my academic years, to leveraging the potential of immune cells to fight malignancies in my industry experience. I have developed expertise in process development for cell therapy. Working cross-functionally, I have managed and mentored scientists to elevate team capabilities leading and coordinating the efforts to bring a bench-top CART process to the 1L clinical-scale production to the manufacturing site, also contributing to the technical sections of the IND filing. I’ve also developed and optimized 3 additional processes, one CART for solid tumor and two for the generation of the cell starting materials from the peripheral blood of healthy donors. I am well versed with the state of the art technologies for closed and automatic operation when working with cells in a manufacturing GMP compliant setting, from cells isolation to formulation while covering a variety of gene modification approaches, from LVV to AAV and from TALEN to CRISPR-Cas9. In order to effectively provide a process in a timely manner, I’ve relied on scale-down model tools when possible as well as the Quality-by-Design and Design-of-Experiment approaches to define the critical process parameters and the optimal space for the each operation. I have extensive experience in cell based assays, cell culture techniques and flow cytometry. During my industry experience I become familiar with the quality and regulatory requirements that should be kept in mind when developing or optimizing a process. Moreover, I collaborated very closely with the analytical team in order to have early assessment of the product quality based on the target product profile. Collaboration across teams is my strength for building a reliable and fast-pace working environment.