Journal
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
Volume 10, Issue 3, Pages 621-634Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s13346-020-00721-8
Keywords
HIV; Quality-by-design; Scale-up; Microfluidics; Industrial translation; Nanoparticles
Funding
- European Union's Horizon 2020 research program (NanoPilot project) [646142]
- Xunta de Galicia's Grupos de referencia competitiva [ED431C 2017/09]
- predoctoral FPU grant from the Spanish Ministry of Education, Culture and Sports [FPU14/05866]
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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. Graphical abstract
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