Our Products are referred to here as "nanomedicine" according to their unique biophysical and biological features. Our APIs are formulated with our novel polymer excipient to create synthetic "pathogen-like" nanoparticles. The nanomedicine formulation is essential to achieve potent antigen expression from the pDNA and antigen presentation by dendritic cells. This is critical for the intensification of antigen-specific immune responses in people with chronic diseases.
The "pathogen-like" nanoparticles - created with the help of a synthetic polymer (mannosylated linear polyethyleneimine, PEIm) - have the size and the shape of spherical viruses that naturally evolved to deliver nucleic acids to the cells. These nanoparticles deliver the pDNA to the cells similarly to viruses, but much safer because replication cannot occur.
A Nanomedicine particle resembles pathogens because it has condensed antigens (pDNA) in its core enveloped with a polymer containing sugar residues on the surface. Each nanomedicine particle enters antigen-presenting cells like pathogens, by receptor-mediated endocytosis. The polymer envelop of each nanomedicine particle protects the pDNA core from endosomal degradation and supports antigen expression.
We have performed the detailed physico-chemical characterization of the nanomedicine according to the approval guidelines using validated assays, and systematically investigated the variability of nanomedicine components and their relationship with the structure, in vitro biological activity and stability of nanomedicine (please refer for more published information, Toke et al. IJP, 2010).
One of the unique features of our platform technology is that by changing only the nucleotide sequence of the API we can rapidly and costs effectively develop new Products. Such a change modifies the antigen repertoire and specificity of the Product but does not influence the manufacturing methods. Therefore, we have been developing commercial-scale biological manufacturing processes and validated quality control methods.