Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin

This study aims to highlight the impact of physicochemical properties on the behavior of nanopharmaceuticals and how much carrier structure and physiochemical characteristics weighs on the effects of a formulation. For this purpose, two commercially available nanosimilar formulations of Doxil and their respective carriers were compared as case-study. Although the two formulations were “similar”, we detected different toxicological effects (profiles) in terms of in vitro toxicity and immunological responses at the level of cytokines release and complement ac-tivation (iC3b fragment), that can be correlated with the differences in the physicochemical properties of the formulations. Shedding light on nanosimilar key quality attributes of liposome based materials and the need for an accurate characterization including investigation of the im-munological effects is of fundamental importance considering the global raise of lipid-based technologies as mRNA nanocarriers applied to nanovaccines toward COVID-19 and in the next future against cancer.

LIPŞA Dorelia;  MAGRI Davide;  DELLA CAMERA Giacomo;  LA SPINA Rita;  CELLA Claudia;  GARMENDIA AGUIRRE Irantzu;  MĖHN Dóra;  RUIZ MORENO Ana Maria;  FUMAGALLI Francesco;  CALZOLAI Luigi;  GIORIA Sabrina; 

2023-09-11

MDPI

JRC133703

1422-0067 (online),   

https://www.mdpi.com/1422-0067/24/17/13612,    https://publications.jrc.ec.europa.eu/repository/handle/JRC133703,   

10.3390/ijms241713612 (online),