Research to achieve mass production of platelets is being conducted as follows
Basic research involves the genetic, molecular and cellular analyses to find the optimal conditions for the immortalized megakaryocyte precursor cells to propagate, mature and produce platelets.
We are proceeding to establish high-quality megakaryocyte cell lines and prepare a master cell bank (MCB). Based on the results obtained from the basic research, we have achieved large scale platelet production using bioreactors. Developments in platelet formulation is also conducted.
We have created an evaluation system based on the results obtained from in vitro and in vivo analyses to guarantee the quality and efficacy of the manufactured platelets.
With an aim of receiving an early approval, we have submitted a clinical trial notification to the Ministry of Health, Labor and Welfare and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan.
Simultaneously, preparations are underway for obtaining the proof of concept (POC) and Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) as early as possible.
With an aim to create innovative products and to make practical production possible, our development work requires high degree of expertise in technical aspects like development of reagents, culture media, platelet separation and concentration, stable preservation of platelets, and in regulatory affairs and clinical development. To achieve this, we collaborate with domestic and foreign research institutions and medical manufacturers to cover broad range of topics. We aim to share the information and technologies we have developed to the public and to use this project as a model for open innovation project, there by contributing to open a world of new opportunities in transfusion medicine.