Development of non-invasive delivery of biopharmaceuticals equipped with novel membrane permeation technology and their translational research

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The purpose of this study was to establish non-invasive delivery systems for biodrugs based on new delivery tool: cell-penetrating peptides (CPPs) and to perform translational research, and the following results were obtained: 1) Elucidation of main mechanism of membrane permeation enhancing effects by CPPs, 2) Novel peptide sequence (PenetraMax) that is superior to natural CPPs was obtained by in silico exploratory research using an artificial neural network, 3) Clarification of CPPs' high safety systemically and locally by in vivo toxicity tests. Furthermore, useful knowledge for development of the clinical formulations of CPPs, and based on the above results, an experimental conditions to perform oral PET imaging studies were established.