Abstract

Industrialization of Regenerative Medicine - Standards are the Key

Tatsuo Heki, Senior Expert, Fujifilm Corporation

Industrialization of a particular field means making its product/service available anytime, anywhere and to anybody. Written standards in the field of regenerative medicine will form a common international “language” for use by the stakeholders including manufacturers, suppliers and regulators to support effective delivery of cell-based medicines, and is the centerpiece of industrialization.  ISO/TC 276 (International Organization for Standardization Technical Committee 276) Biotechnology. is developing standards in the areas of terms and conditions, biobanks and bioresources, analytical methods, bioprocessing and data processing in the field of biotechnology processes. ISO/TC 276 will contribute to regenerative medicine by establishing a common language for analytical methods and bioprocessing so that there is a more harmonized understanding by the stakeholders in the efforts from translation of research to transportation of cells for therapeutic use.