Initiatives of AMED-MPS Projects for Industrial Implementation of MPS in Japan and Collaboration with Asia
Seiichi Ishida,
Professor,
Sojo University
AMED-MPS2 project started in 2022 and has been leading the initiative for the implementation of MPS originated in Japan to industries. Due to the unique nature of the culture environment of MPS, it has become clear that there are "points to consider" that differ from conventional culture methods in order to maintain healthy cell function,e.g. cell functionality, cell adhesion property, and medium perfusion conditions. Our efforts how to deal with such requirements for MPS industrial implementation will be introduced. Beyond these efforts will be the regulatory acceptance of the data obtained by MPS. Discussions what MPS should be as the test methods for regulatory usage based on the considerations will be presented, which are taking place in AMED MPS-RS (RS stands for “regulatory science”). MPS-RS has launched MPS Consortium for Industrial Implementation and Regulatory Acceptance, which gives the discussion table among four stakeholders, academia, supplier, end user, and regulator. The MPS Consortium are also collaborating with iMPSS, founded in this June, and its Asia-Pacific regional chapter. These activities will be presented.
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