Despite a very active research in the field of nanomedicine, only a few nano-based drug delivery systems have reached the market. The “death valley” between research and commercialization has been partially attributed to the limited characterization and reproducibility of the nanoformulations. Our group has previously reported the potential of a peptide-based nanovaccine candidate for the prevention of SIV infection in macaques. This vaccine candidate is composed of chitosan/dextran sulfate nanoparticles containing twelve SIV peptide antigens. The aim of this work was to rigorously characterize one of these nanoformulations containing a specific peptide, following a quality-by-design approach. The evaluation of the different quality attributes was performed by several complementary techniques, such as dynamic light scattering, nanoparticle tracking analysis, and electron microscopy for particle size characterization. The inter-batch reproducibility was validated by three independent laboratories. Finally, the long-term stability and scalability of the manufacturing technique were assessed. Overall, these data, together with the in vivo efficacy results obtained in macaques, underline the promise this new vaccine holds with regard to its translation to clinical trials.
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Authors would like to thank the RIAIDT-USC analytical facilities, for the microscopy imaging. All the icons used in the graphical abstract were designed by Freepick at www.flaticon.com.
This work was supported by the European Union’s Horizon 2020 research program (NanoPilot project – grant agreement number 646142) and by Xunta de Galicia’s Grupos de referencia competitiva (grant number ED431C 2017/09). T.G. Dacoba acknowledges a predoctoral FPU grant from the Spanish Ministry of Education, Culture and Sports (grant number FPU14/05866).
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Dacoba, T.G., Ruiz-Gatón, L., Benito, A. et al. Technological challenges in the preclinical development of an HIV nanovaccine candidate. Drug Deliv. and Transl. Res. (2020). https://doi.org/10.1007/s13346-020-00721-8
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