Standards in bioresource centers: practice in Japan

Standards in bioresource centers:
practice in Japan
Hiroko Kawasaki
Industrial Innovation Division,
Biological Resources Center (NBRC),
National Institute of Technology and Evaluation (NITE), Japan
Seminar: Standardization and ethical issues for biomedical collection
30th January 2019
The Sukosol hotel, Bangkok, Thailand
1

Outline
1. Organizational Structure of NITE and NBRC
2. Activity of NBRC Culture Collection (microbial
biobank)
3. BRC (biobank) and Standardization
4. Introduction of International standard related to
biobanking
5. Responding to new international accreditation
standards (ISO 20387) in Japanese biobanks
2

National Institute of Technology
and Evaluation (NITE)
NBRC, as one of the leading
public biological resource
centers in the world, has
been collecting, preserving
and providing high-quality
microbial resources and
information.
Collecting and
transmitting information
required for total risk
assessment and
management of chemical
substance
Constructing and
administering reliable
conformity systems
that meet
international
standards
Collecting and
transmitting
information
related to product
safety and comfort
in daily life
Biological Resource Center
Consumer Product Safety Center
Chemical Management Center
International Accreditation Japan
Emerging Technology
Evaluation
Development of testing and evaluating
methods for emerging technologies
3

Tohoku Regional Office
NITE Headquarters &
Genome analysis
laboratories
NITE Biological Resource
Center (NBRC)
Patent Depository Centers
(NPMD and NITE-IPOD)
Tokyo
Kazusa
Sendai
Location of
NITE Biological Resource Center (NBRC)
Osaka
Global Center for
Evaluation Technology
&
Kansai Biotechnology
Office
NITE Long-term Preservation Center
4

Outline
biobank)
biobanking
5

Activities, Budget and Employment of NBRC
 Total annual budget :
 10 Mil $ from Government
 1 Mil $ from Industries
 Employment: total 150
 80 permanent
 70 part-time
 Collection: 91,531 strains
 NBRC Cultures (Cataloged
cultures) 32K strains
 R&D Strains (Screening
sources) 59K strains
Industrial
support
Biosafety &
Inspection
International
Cooperation
Culture
Collection
Genome
Analysis
Patent
Depositary
Biobanking
6

antibiotic
Medical
Toxin
Virulence factor
Antibiotic resistance
NBRC
Biological Resource Center, NITE
Food industry Bioremediation
Genetic recombination
biofuel
bioplastic
detergent
7

NBRC Culture Collection strains
(As of March 31, 2018)
Filamentous
fungi
37%
Bacteria
33%
Yeast
15%
Actinomycetes
12%
Microalgae
2%
Archaea
1%
Bacteriophages
0.4%
■Filamentous fungi 11,906
■Bacteria 10,450
■Yeasts 4,768
■Actinomycetes 3,885
■Microalgae 705
■Archaea 335
■Bacteriophages 117
Total Holdings 32,166
■Human cDNA clones 55,399
■Human GatewayTM
Entry Clones
43,567
8

■Domestic Industry 3,584
■Domestic Academy 3,158
■Foreign Industry & Academy 499
■Domestic other 115
■Foreign Exchange 54
■Foreign other 23
■Domestic Exchange 7
Number of strains distributed 7,440
NBRC CC strains Distribution
Price (¥)/strain
Domestic
Industry 8,000
Academic 4,000
Foreign
Industry & Academy 8,000
Domestic
Industry
48%
Domestic
Academy
42%
Foreign
Industry
&
Academy
7%
Domestic
other
2%
Foreign
Exchange
1%
Foreign
other
0.31%
Domestic
Exchange
0.09%
(As of March 31, 2018)
9

Distribution from NBRC Culture Collection
0
2,000
4,000
6,000
8,000
10,000
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1,603
2,2252,1362,1992,4462,4652,411
2,796 2,780 2,919 2,913
2,822
2,628 2,648 2,600 2,620
5,518
6,538
6,144
7,213
8,019
7,363
7,798
8,819
9,354
9,149
8,824
8,378
7,800
9,778
9,060
7,584
Order
Resources
Total 7,584 = 7,440 (microbes) + 144 (DNA resources)
Total 2,620 = 2,532 (microbes) + 88 (DNA resources)
(FY)
(644 strains for abroad)
10

Outline
biobank)
biobanking
11

①collection
Isolation of
microorganisms from
soil and water
collected from various
domestic and overseas
environments
Extreme environment
various nature sample
Deposit of useful
microorganisms from
researchers
Pure cultures
②identification
Classification and
identification of
microorganisms
Electron microscopic observation
③preservation
Long-term
preservation of
identified
microorganisms and
their data
⑤distribution
Distribute based on
user's request
④Additional data
Analyze genes and its
functions, and create a
database
DNA sequencing
Deep
freezer
ampule
catalog
Microbe.
Provide microbial
resources and
functional gene
information possessed
by microorganisms
database
Database of microbial strain
Record of preservation process
Estimate a useful gene etc.
微生物が生産する物質の同定
Microbial identification
Process of BRC management
12

BRC (biobank) and Standardization
 Standardization of BRC management for quality control of
bioresources and improvement of services
• ISO 9001: Quality management systems
• ISO 9001 is a standard that sets out the requirements for a quality
management system. It helps businesses and organizations to be more
efficient and improve customer satisfaction.
• ISO 20387: Biotechnology -- Biobanking -- General requirements for
biobanking
• This document specifies general requirements for the competence,
impartiality and consistent operation of biobanks including quality control
requirements to ensure biological material and data collections of
appropriate quality.
 Providing standard microorganisms (Test strain) to support
domestic and international standard tests
• Example: Microorganism for evaluation test such as antibacterial activity
NBRC
13

Standard operation processes for microbial BRC (ISO 9001)
①Acceptance of microorganism
deposit
②Microbial preservation
④Transfer/Shipping
③QC of product
Confirmation of
application
Strain
Strain
conformation
Deposit by
researchers
L-乾燥品
Separation source ·
Country of origin
Culture conditions
Quality
control
culture preservation
Confirmation
of application
form
Mailing of
products,
invoices,
etc.
Distribu-
tion by
research-
ers
Contact of
shipping
schedule
date
Long-term
Preservation
（-170℃）
・Confirmation of identity
by DNA information
and mass spectrometry
identity
・Confirmation of color
tone, shape, etc.
purity
ISO9001
・Purpose of use · Safety level
· Confirmation of Regulation of Cartagena Act, Foreign Exchange
and Foreign Trade Law, Plant Protection Law etc
Confirmation of survivability
Confirmation of contamination
Making
ample
users14

BRC (biobank) and Standardization
 Standardization of BRC management for quality control of
bioresources and improvement of services
• ISO 9001: Quality management systems
• ISO 9001 is a standard that sets out the requirements for a quality
management system. It helps businesses and organizations to be more
efficient and improve customer satisfaction.
• ISO 20387: Biotechnology -- Biobanking -- General requirements for
biobanking
• This document specifies general requirements for the competence,
impartiality and consistent operation of biobanks including quality control
requirements to ensure biological material and data collections of
appropriate quality.
 Providing standard microorganisms (Test strain) to support
domestic and international standard tests
• Example: Microorganism for evaluation test such as antibacterial activity
NBRC
16

International Standards (ISO)
ISO 846:1997(E): Plastics - Evaluation of the action of microorganisms
ISO 10705-1:1995(E): Water quality - Detection and enumeration of bacteriophages - Part 1:
Enumeration of F-specific RNA bacteriophages
ISO 10705-2:2000(E): Water quality - Detection and enumeration of bacteriophages - Part 2:
Enumeration of somatic coliphages
ISO 13125:2013(E): Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for
antifungal activity of semiconducting photocatalytic materials
ISO 13629-1:2012(E): Textiles - Determination of antifungal activity of textile products - Part 1:
Luminescence method
ISO 20743:2007(E): Textiles -Determination of antibacterial activity of antibacterial finished products
ISO 22196:2011(E): Measurement of antibacterial activity on plastics and other non-porous surfaces
Japanese Industrial Standards (JIS)
JIS A 5756:2006 Building gaskets and Building structural gaskets -Materials in prefprmed solid
vulcanizates used for sealing glazing and panels
JIS A 6909:2010 Coating materials for textured finishes of buildings (Amendment 2)
JIS A 6922:2010 Adhesives for wallpaper and wallcoverings for decorative finish and TATEGU
(Amendment 1) and 9 others
The Japanese Pharmacopoeia (15th edition)
4.02 Microbial assay for antibiotics
4.05 Microbial limit test
4.06 Sterility test
21. Quality control of water for pharmaceutical use and 5 others
18
We need high
quality microbs in
strain level.

19
Agreement for deposition and distribution for NBRC

Outline
biobank)
biobanking
20

ISO is an independent, non-governmental international organization with a
membership of 162 national standards bodies.
Through its members, it brings together experts to share knowledge and develop
voluntary, consensus-based, market relevant International Standards that support
innovation and provide solutions to global challenges.
Central Secretariat is located in Geneva, Switzerland.
The ISO story began in 1946 when delegates from 25 countries met at the Institute
of Civil Engineers in London and decided to create a new international
organization ‘to facilitate the international coordination and unification of
industrial standards’. On 23 February 1947 the new organization, ISO, officially
began operations.
Today ISO have members from 162 countries and 783 technical bodies to take care
of standards development. More than 135 people work full time for ISO’s Central
Secretariat in Geneva, Switzerland.
URL: https://www.iso.org/home.html
What is International Organization for
Standardization (ISO)?
21

• International Standards make things work. They give
world-class specifications for products, services and
systems, to ensure quality, safety and efficiency. They
are instrumental in facilitating international trade.
• ISO has published 21932 International Standards
and related documents, covering almost every
industry, from technology, to food safety, to
agriculture and healthcare. ISO International
Standards impact everyone, everywhere.
What are standards?
22

https://www.iso.org/structure.html
The ISO Council takes care of
most governance issues. It
meets twice a year and is made
up of 20 member bodies, the
ISO Officers and the Chairs of
the Policy Development
Committees CASCO, COPOLCO
and DEVCO. Under the Council
are a number of bodies that
provide guidance and
management on specific
issues:
The management of the
technical work is taken care of
by the Technical Management
Board. This body is also
responsible for the technical
committees that lead standard
development and any strategic
advisory boards created on
technical matters.
ISO governance structure
General Assembly
Council President’s Committee
TMB(Technical Management Board)
Council standing
Committee
Policy Development
Committee
TC (Technical Committees)
SC (Sub-committee)
WG (Working Group)
PJ (Project)
Reporting/responsibility
Advisory
23

<https://www.iso.org/committee/4514241.html>
ISO/TC 276のScope
Standardization in the field of biotechnology processes that includes the following topics:
Terms and definitions;
biobanks and bioresources;
analytical methods;
bioprocessing;
data processing including annotation, analysis, validation, comparability and
integration;
metrology.
ISO/TC 276 Biotechnology will work closely with related committees in order to identify
standardization needs and gaps, and collaborate with other organizations to avoid
duplications and overlapping standardization activities.
24

Scope of ISO/TC 276
Standardization in the field of biotechnology processes that includes the
following topics:
• Terms and definitions;
• biobanks and bioresources;
• analytical methods;
• bioprocessing;
• data processing including annotation, analysis, validation, comparability
and integration;
• metrology.
ISO/TC 276 Biotechnology will work closely with related committees in
order to identify standardization needs and gaps, and collaborate with
other organizations to avoid duplications and overlapping standardization
activities.
The committee will not pursue subjects within the scope of other TCs
including but not limited to ISO/TC 212 and ISO/TC 34/SC 16.
17 ISO standards under development,
30 P-members
14 O-members 25

ISO/TC 276 members
26
Secretariat: DIN（Germany）
Secretary: Ms. Lena Krieger （DIN）
Chairperson: Mr. Ricardo Gent until end 2019
Creation date: 2013
Participating Members (30)
Brazil (ABNT)
France (AFNOR)
United States (ANSI)
Austria (ASI)
United Kingdom (BSI)
Germany (DIN)
Denmark (DS)
Egypt (EOS)
Colombia (ICONTEC)
Luxembourg (ILNAS)
Portugal (IPQ)
Argentina (IRAM)
Iran, Islamic Republic of (ISIRI)
Japan (JISC)
Korea, Republic of (KATS)
Belgium (NBN)
Ireland (NSAI)
Australia (SA)
China (SAC)
Canada (SCC)
Finland (SFS)
Israel (SII)
Sweden (SIS)
Sri Lanka (SLSI)
Switzerland (SNV)
Nigeria (SON)
Singapore (SPRING SG)
Tanzania, United Republic of (TBS)
Thailand (TISI)
Italy (UNI)
Observing Members (13)
India (BIS)
Mexico (DGN)
Ukraine (DSTU)
Estonia (EVS)
Ecuador (INEN)
Lithuania (LST)
Mongolia (MASM)
Hungary (MSZT)
Netherlands (NEN)
Poland (PKN)
Norway (SN)
Spain (UNE)
Czech Republic (UNMZ)
2017/7/28
(https://www.iso.org/committee/4514241.html?view=participation)

Working Group in ISO/TC 276
 ISO/TC 276/WG 1 – Terminology
 ISO/TC 276/WG 2 – Biobanks and bioresources
 ISO/TC 276/WG 3 – Analytical methods
 ISO/TC 276/WG 4 – Bioprocessing
 ISO/TC 276/WG 5 – Data processing and integration
27
(https://www.iso.org/committee/4514241.html)
• ISO/DTR 20386 Inventory of biotechnology-related terms
• ISO/IS 20387 Biotechnology -- Biobanking -- General requirements for
biobanking
• ISO/CD 21899 Biotechnology -- Biobanking -- General requirements for the
validation and verification of processing methods in biobanks
• ISO/AWI TR 22758 Biotechnology -- Biobanking -- Implementation guide for
ISO 20387
• ISO/AWI 21710 Biotechnology -- Data management and publication in
microbial biological resource centers
 Proposal document related to the microbial BRC management

Quality Management Standard – ISO 9001
User'srequest
Animal
Biobanks
Specifics
for
Aminal
Biobanks
Plant
Biobanks
Specifics
for
plant
Biobanks
Microbs
Biobanks
Specifics
for
Microbs
Biobanks
Human
specimen
Biobanks
Specifics
for
Human
specimen
Biobanks
ISO 20387 (Biobanking accreditation）
Proposal of specific requirements with general
requirement (ISO 20387)
Sharing of intention of Bio Bank and users
ISO 21899
（validation & verification for biobanking）
TC276 Biobanking standards
Proposed standards:
ISO 20388, 20389, 21709,
22859-1, and 22860,
ISO/TR 22758
guidance for
ISO 20387
ISO/AWI
21710:
microbial
biobank
database
28

ISO 20387 https://www.iso.org/standard/67888.html
29

This document specifies general requirements for the competence, impartiality
and consistent operation of biobanks including quality control requirements to
ensure biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking, including
biobanking of biological material from multicellular organisms (e.g. human, animal,
fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies, and others can also use this document in
confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed
production, laboratories undertaking analysis for food/feed production, and/or
therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also
apply to specific topics covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic
and treatment purposes ISO 15189 and other clinical standards are intended to
apply first and foremost.
ISO 20387: General requirement of Biobanking
30

Outline
biobank)
3. BRC and Standardization
biobanking
31

Biobanking in Japan
• Human biobank (human specimens and cells)
– Associated with hospital and medical filed of
University
• Mammalian biobank
• Plant biobank (Seed bank etc.)
• Microorganism biobank*
• Others
NBRC
National
BioResource
Project
(Several
organizations)
*Supported by Japan Society for Microbial
Resources and Systematics (JSMRS)
32

http://www.biobank.amed.go.jp/biobank/index.html#biobankList
List of biobank
All DNA Bｌood Specimen Cell
Name of the
organization
Sample type
Number of
samples to be
stored
Disease name
Terms of use and
contact information
DNA (DNA adjusted in
concentration at 100 ng /
μL stored at 4 ° C) /
serum (stored at -150 °
C in the vapor phase of
liquid nitrogen tank)
BioBank, Japan
（BBJ)
33

Human Baiobank in Japan
 Regular biobank liaison meeting as a forum for
exchanging opinions between the biobank and
users (stakeholders) by government support
 Initiation of various government support programs
(network, ethical issues, implementation of
external provision)
 National Biobank network support
Leadership of response to ISO 20387
34

Conclusions
• I believe that high-quality biological resources
support high-quality research and, as a result,
support human health and productive life.
• International standards and their arguments
affect the provision of high quality biological
resources in biobanking.
35

Thank you for your attention.
36

Standards in bioresource centers: practice in Japan

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