Research to achieve mass production of platelets is being conducted as follows
Through various analyses of genes, molecules, and cells, the optimal conditions for immortalized megakaryocyte precursor cells to propagate, mature, and release platelets are being examined.
We are proceeding to establish high-quality megakaryocyte lines and prepare a master cell bank (MCB). The data obtained from basic research has allowed the expansion of platelet production in a larger scale and formulation of platelet product with various manufacturing devices including a fermenter.
Through evaluation and analysis of methods used in test tubes and through in vivo testing in animals, we are creating an evaluation system that will guarantee the quality and efficacy of the manufactured platelets produced.
In Japan, we are making preparations to submit a clinical trial notification to the Ministry of Health, Labour and Welfare and the Pharmaceutical and Medical Devices Agency, with the aim of receiving early approval.
At the same time we are proceeding with the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, to get a proof of concept (POC) as early as possible as early as possible.
In order to make practical production possible and create innovative new products, our development work requires a high degree of expertise, notably in technical developments of reagents, culture media, platelets separation/condensation and stable preservation of platelets, in addition, in regulatory affairs or clinical development to create innovative new drug products.
For that reason, collaboration with domestic and foreign research institutions and medical manufacturers is indispensable across the broad in a range of fields. We aim to make available the techniques and information we have obtained through our research so far release into the public, and use this project as a type of open innovation project and contribute to the building of a new transfusion infrastructure for a new era.