Clinical Product Development

Members

Professor
Hitoshi Sasaki
Assistant Professor
Sayuri Nakamae
Assistant
Masako Tanaka

Activities

This department promotes the process of pharmaceutical products to clinical commercialization and researches on the systems and regulations related to the clinical development process. We have been engaged in the development of clinically usable targeted formulations mainly for gene and nucleic acid mediated medicines. And currently, we are promoting the development of novel formulations and conducting regulatory research. In particular, we have developed a novel targeted formulation for nucleic acid vaccine “nanoballs,” which is highly biocompatible, efficiently delivers pDNA and mRNA encoding antigens to antigen-presenting cells (APCs), and can strongly induce antigen specific immunity. In collaboration with Professor Kenji Hirayama and his colleagues, we have already succeeded in applying pDNA encoding antigens of malaria and schistosomiasis on nanoballs to induce specific humoral and cellular immunity against these parasites and to obtain strong growth suppression of the parasites. Now, we are constructing another nanoball formulation for mRNA vaccine and developing a inhalational mRNA vaccine against respiratory tract infections such as the SARS-CoV-2.
Nucleic acid is water-soluble negatively charged polymer and gene and nucleic acid mediated medicines, which have been developed in recent years, are easily degraded and hardly taken by the cell in the body. Therefore, a novel drug delivery system that can stabilize and deliver those medicines to target cells is essential. The novel targeted formulations developed in our laboratory can be widely applied to gene and nucleic acid medicines, showed extremely high safety, target efficiency, and clinical applicability, and can help many pharmaceutical companies and researchers to solve their problems.

Recent main research achievement

  1. Ko et al. Pharmaceutics 2024; 16(4): 522
  2. Nakamae et al. Front Immunol 2023; 14: 1116299.
  3. Muro et al. Biol Pharm Bull 2023; 46(2): 237-244.
  4. Kurosaki et al. Pharmaceutics 2021; 13(11): 1983.
  5. Kurosaki et al. Drug Deliv 2021; 28(1): 1585-1593.