Genetic Immunity, a multi-national biopharmaceutical company developing nanomedicine vaccines today announces publication of the Company's innovative work to develop a stable liquid formulation to deliver a novel nanomedicine. Appearing in the International Journal of Pharmaceutics, the paper addresses how Genetic Immunity was able to overcome significant hurdles facing the field to successfully formulate the first topically administered nanomedicine therapeutic vaccine for the treatment of HIV/AIDS, DermaVir.
“We found several additional quality requirements of the components that were essential both to establish the optimal relationship between physicochemical properties and biological activity of DermaVir and to ensure reproducible manufacturing of a stable formulation. It became apparent that the current state-of-the-art approaches to sourcing, testing and manufacturing were insufficient.”
"Biological activity of DermaVir depends upon its nanomedicine formulation that is essential for the potent expression of plasmid-DNA-encoded antigens. During Phase I and II clinical trials, DermaVir formulation required on-site admixture of three separate components followed by patient administration within three hours. We report here the development of a stable single liquid nanomedicine formulation, a significant milestone in developing DermaVir as a commercially viable global product to treat HIV/AIDS," commented Julianna Lisziewicz, PhD and CEO of Genetic Immunity.
Engineering novel nanomedicines presented Genetic Immunity with challenges not faced in the development of traditional biotechnology products. "One challenge in clinical nanomedicine development is to produce a stable formulation with reproducible manufacturing methods," explained Genetic Immunity's Enikö Töke, PhD. "We found several additional quality requirements of the components that were essential both to establish the optimal relationship between physicochemical properties and biological activity of DermaVir and to ensure reproducible manufacturing of a stable formulation. It became apparent that the current state-of-the-art approaches to sourcing, testing and manufacturing were insufficient."
Genetic Immunity implemented "Quality-by-Design" in biologic product development to manufacture a nanomedicine resulting in a new formulation of pDNA surrounded by a chemical polymer capable of maintaining the physical stability and biological activity of DermaVir at 4ºC.
These discoveries will support DermaVir as it enters into Phase II/III human trials as a topically administered nanomedicine therapeutic vaccine. "Our Phase I trial demonstrated the preliminary safety and immunogenicity of DermaVir in HIV-positive people treated with HAART," Lisziewicz explained. "We have now also obtained Phase II data showing safety, immunogenicity and viral load reductions when DermaVir is used for initial treatment of HIV-infected individuals. This is the human proof of concept of our topical nanomedicine vaccine technology. It is our belief that DermaVir will become the first nanomedicine vaccine developed to reconstitute HIV-specific immunity with the potential to maintain the health of people living with HIV infection."
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