Open Stage Seminar Oct. 13 (Fri.) ,2017 13:55-14:25

【Special Seminar ③】

Forum for Innovative Regenerative Medicine


Tatsuo Heki


Yutaka Yanagita

Astellas Pharma

What is standards, what is going on in ISO/TC 276 Biotechnology

Industrialization of a particular field means making its product/service available anytime, anywhere and to anybody. Developing international standards, i.e. common language among various stakeholders, is the centerpiece of industrialization. With this aspiration in mind, FIRM has been pursuing international standardization in the field of regenerative medicine since 2013.
ISO/TC 276 (International Organization for Standardization Technical Committee 276) Biotechnology. covers standardization in the field of biotechnology processes including analytical methods and bioprocessing, in both of which significant needs for standardization in the field of regenerative medicine are identified. Currently, FIRM members are leading development of standards for ancillary materials and cell transportation in ISO/TC 276.
FIRM made and is making significant contribution to the operation of ISO/TC 276. FIRM organized the ISO/TC 276 meetings, held in Tsukiji Tokyo in 2015 (picture on the right). FIRM will host the ISO/TC 276 Plenary Meeting in 2019.
FIRM organizes Japan Mirror Committee for ISO/TC 276 and Committee to Standardize Foundation for Cell Characterization and Cell Production. Both committees consist of experts from academia, government and industry.