CIBER: Japanese activity for biobanking sustaining
reproducibility
Hiroki Nakae1, Junko Ikeda1, Koh Furuta2
1. Japan Multiplex bio-Analysis Consortium, Tokyo, Japan.
2. Kanagawa Cancer Center Hospital, Yokohama, Japan.

CIBER’s BASIC PRINCIPLESREPRODUCIBILITYCIBER has been established to support thesocial infrastructure (biobanks & biobanking) forthe citizens.
Donation ofbiospecimens

Benefits

CITIZENS

ISO 20387:2018
Biotechnology -- Biobanking -- General requirements forbiobanking
ISO/AWI TR 22758
Biotechnology -- Biobanking -- Implementation guide forISO 20387

Biobanks &Biobanking

Development &Innovations

ISO standards are the systems to assure thatthe products and services are produced basedon the reproducible data. Newly published ISO20387 and soon-to-be published TR 22758 will
work for the biobanking domains.

Collection &Sharing

Toolbox: Conformity Assessment

Slide courtesy of C. Allocca (NIST)

1st Party:
Self-declaration

CIBER PROSPECTUS
The direction of the current medical services in the world is towards the precision medicine
based on the genomic medicine. One of the infrastructures of this environment is the storage
and/or utilization of bioresources including data. At this point in time, discussions regarding
standardization are started in the ISO framework. Some criticized that standardization isnegative to progress in technologies. History tells us, however, in some situation
standardization may be positive to innovation if direction of standardization is properly
placed.
We can say that discussions shall be driven by users of biorepositories, not by providers.
History indicates us again that innovations are with users of technologies. Although theprecision medicine seems promising, some critics point out that the precision medicine mayproduce medical divide. One solution to these inputs could be to set up the opened
framework of biological and environmental repositories. Considering the roles of biologicaland environmental repositories, it is urgent for the current generation to prepare andmaintain this framework in a sustainable way.
Along with declining birthrate and the following population aging, it is easily assumed thatpublic funds may not afford to provide supports to all the social infrastructures. Under thesecircumstances, users of biological and environmental repositories as private partners areexpected to participate to this framework in a proactive and pre-competitive manner.
We, mainly users of biological and environmental repositories, decided to network
horizontally and further set up a corporation of “Council for Industrial use of Biological andEnvironmental Repositories (CIBER)” to commit to support a part of roles of medical
infrastructure under international standards. Goal of a corporation of “Council for Industrial
use of Biological and Environmental Repositories (CIBER)” is to support the social
infrastructure without medical divide not only to ourselves but also to our next generations.

2nd Party: Agreement

3rd Party: Accreditation
Accreditation is a form of
3rd Party Assessment

Neutrality Principle: Content of standard shall not state a preference for aform or one type of assessment over another

CIBER’S MISSION: CREATING INFRASTRUCTURE★Providers’ Network★
Mega Biobanks
National Center
Biobank
Network（NCBN）

AMED networks★Networking★
Medium size BB
UNIV
Research institutes

PrefecturalPrivate bb

2018, January 22Founders★ Networking★
Small size BB
Univ

CENTER

Univ

CENT
ER

PRI
VATE

PRI
VATE

PRI
VATE

PRI
VATE

★Providing Standards★
・ISO Standards・SOPs
・Best PracticesCIBER NETWORKS
Pharma
製薬企業
製薬企業

International
Cooperation

IVD companies
診断薬企業
診断薬企業

Pharmaceutical
Bio Tech
IVDs Companies

BiobankBusinessNetworkPartners

Bio Tech
研究者
研究者

Researchers
研究者
研究者★Users’ Network★

CONCLUSIONSThe non-profit organization, CIBER, based in Tokyo Japan focuses on:

ResearchPartners

Government
Agencies

i. to introduce the standardization systems to guarantee thereproducible results for biobank stakeholders & patients.
ii.to facilitate setting up business models to meet the needs ofbiobank users/customers.
iii.to facilitate applying internationally common platforms,
standardized methods, and best practices.
iv.to facilitate setting up conformity assessment eco system including
self-assessment, contract, and/or certification/ accreditation.
v.to facilitate innovations in the biotechnology field.

Council for Industrial use of Biological and Environmental Repositories

Head Office Location: 6F Sanseido bldg. 2-4-10, Koujimachi, Chiyoda-ku, Tokyo 102-0083 JAPANhttps://ciber.or.jp/