Technological challenges in the preclinical development of an HIV nanovaccine candidate.
Tamara G DacobaLuisa Ruiz-GatónAna BenitoMarlène KleinDamien DupinMa LuoMathieu MentaDesirée Teijeiro-OsorioIraida LoinazMaría J AlonsoJosé Crecente-CampoPublished in: Drug delivery and translational research (2021)
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.
Keyphrases
- clinical trial
- electron microscopy
- big data
- antiretroviral therapy
- drug delivery
- hiv infected
- hiv positive
- human immunodeficiency virus
- quality improvement
- hiv aids
- stem cells
- health insurance
- hiv testing
- mesenchymal stem cells
- cell therapy
- randomized controlled trial
- dendritic cells
- cancer therapy
- men who have sex with men
- deep learning
- south africa
- machine learning
- artificial intelligence
- human health
- iron oxide