Advanced nanomedicine characterization by DLS and AF4-UV-MALS: application to a HIV nanovaccine

Abstract Nanoformulations are complex systems where physicochemical properties determine their therapeutic efficacy and safety. In the case of nanovaccines, particle size and shape play a crucial role on the immune response generated. Furthermore, the antigen’s integrity is also a key aspect to control when producing a nanovaccine. The determination of all those physicochemical properties is still an analytical challenge and the lack of well-established methods hinders the access of new therapeutics to the market. In this work, robust methods for the characterization of a novel HIV nanoparticle-based vaccine produced in good manufacturing practice (GMPs)-like environment were developed. With slightly polydisperse particles ( 90%) with size lower than 250 nm, consistent with more traditional techniques, and revealed a slight change in the structure of the particles induced by the presence of the antigen. Finally, a batch to batch variability lower than 20% was obtained by both DLS and AF4 methods indicating that preparation method was highly reproducible.