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Transcript of The Importance of Standardization in Biobanking ... Ki Hyun Ryu- Standardization of... · The...
The Importance of
Standardization in Biobanking &
Activities of KNRRC
Ki Hyun RYU Chairman, ISO/TC 276 Korean Mirror Committee
Director-General, Korea National Research Resource Center
Professor, Seoul Women’s University
Standardization in biobanking
International Organization for Standardization (ISO)
ISO/TC 276 Biotechnology
ISO/TC 276 Working Group Activities
Korea’s response to ISO/TC 276
Korea National Research Resource Center
Standardization in
Biobanking
Benefits expected from standardization efforts
ISO TC276 General, N129 Strategic Business plan, 2015 4
Technological
development
National &
international
competitiveness
Predictability
of the regulatory
environment
Exchange of
goods and
services
Market access
Standardization
Current status of the global biomarket
ISO TC276 General, N129 Strategic Business plan, 2015; Picture: Lloyd Humphreys and Aaron K. Kim from Noun Project 5
Among 30,000 human protein
coding genes, the current
pharmaceutical products only
aimed at 500 targets
2009 2010
Compound
annual growth
19.7 %
20.5
billio
n
The global biomarket size
Contribution to the development of biomarkers and
personalized medicine
ISO TC276 General, N129 Strategic Business plan, 2015
Good
governance
6
# of publications on
microorganisms has increased
Microorganisms were
utilized by mankind for
thousands of years
Their use continues to expand in various sectors such as health, food industry
and environmental maintenance
→ The need for standardized methods on handling microorganisms ▲
→ ISO/TC 276 is developing standards for biobanks
Implications on the microorganism field
ISO TC276 N0129, Ballot on resolution 31, 2015 7
International Organization
for Standardization (ISO)
ISO TC276 General, N129 Strategic Business plan, 2015
About ISO
An independent, non-governmental membership organization
The world's largest developer of voluntary International Standards
9
162 countries
3535 technical
bodies 21133
documents
published
(as of 2015)
My ISO job, 2014
Principal officers Delegates of: -Member bodies -Correspondent members -Subscriber members
General Assembly
Council
Technical
Management Board
(TMB)
Technical
Committees
President’s Committee
Reporting/responsibility
Advisory
Policy Development
Committee
CASCO COPOLCO DEVCO
Council Standing
Committee
Finance Strategy
Strategic and technical
advisory groups and
REMCO
10
The various elements of the ISO
committee structure fit together.
Each technical committee (TC)
and subcommittee (SC) has
chairman and secretary.
Working group (WG) meetings
are attended by the experts
appointed by P-members and
liaison organizations.
My ISO job, 2014 11
International Standard (IS)
‒ Normative; requires extensive
consensus procedures
Technical Specifications (TS)
‒ Normative; for works still under
technical development
Technical Reports (TR)
‒ Informative; data/info on the
perceived “state of the art”
Publicly Available Specification
(PAS)
‒ Normative; published to respond to
an urgent market need
My ISO job, 2014 12
ISO/TC 276 Biotechnology
Creation date: December 12-13, 2013
Secretariat: DIN, Germany
Scope: Standardization in the field of biotechnology processes
WG 1: Terms and definitions
WG 2: Biobanks and bioresources
WG 3: Analytical methods
WG 4: Bioprocessing
WG 5: Data processing and integration
ISO TC276 General, N129 Strategic Business plan, 2015 14
ISO TC276 General, N129 Strategic Business plan, 2015
ISO/TC 276 Plenary Meetings and Working Group Meetings
1st ISO/TC 276 Meeting
December 12-13, 2013
Germany.
2nd ISO/TC 276 Meeting
May 12-15, 2014
Berlin, Germany.
3rd ISO/TC 276 Meeting
April 13-18, 2015
Shenzhen, China.
15
4th ISO/TC 276 Meeting
October 26-30, 2015
Tokyo, Japan.
5th ISO/TC 276 Meeting
May 9-13, 2016
Washington DC, U.S.A.
6th ISO/TC 276 Meeting
October 24-28, 2016
Dublin, Ireland
7th ISO/TC 276 Meeting
May, 2017
Seoul, Korea
Asian
Network
of RRCs
www.iso.lorg 16
P-member
25 O-member
14
ISO
liaisons
14
Org in
liaisons
5 Secretariat
ISO/TC 276 Working Group
Activities
Objectives
Harmonization of existing terminology in the field of Biotechnology rather than
on the standardization of new definitions.
Develop a framework that will help to identify a logical grouping of terms
as well as existing standardized terms and gaps
Analysis of terms and definitions in consensus-based national and
international standards, guidelines and other relevant documents
ISO TC276 General, N129 Strategic Business plan, 2015
Scope
18
Improve access to qualified samples
Unify policies and procedures for biobanks, biological resources
centers, and repositories
Support exchange of biological resources and related data
among biobanks
Stimulate access of partners from the public and private sector
Objectives
ISO TC276 WG2, N0041 Report of the WG2 Convenor, 2015
Elaborating a package of International Standards in the Biobanking field
including human, animal, plant and microorganism resources for Research &
Development (R&D) aspects, but excluding therapeutics.
Scope
19
ISO/NP 20387 General requirements for biobanking
ISO/PWI 21899 Biotechnology -- Biobanking -- General requirements for the
validation and verification of processing methods for biological material in
biobanks into its work programme
Project related to the field of microbiology
Objectives
Developing a package of International Standards for biologically relevant
molecules and entities, including nucleic acids, proteins, and cells
Develop horizontal and vertical / particular standards for industry sectors
‒ Cell characterization
‒ Cell counting and viability
‒ Nucleic acid quantification and sequencing
ISO TC276 General, N129 Strategic Business plan, 2015
Scope
20
Developing International Standards for ensuring consistent, controlled and
traceable processes to give confidence to suppliers and users of products.
ISO TC276 WG4, N0031 ISO/TC276/WG4 “Bioprocessing report of the Secretary”, 2015
Scope
21
Objectives
Ensure that the component materials have a consistent and
reproducible quality
Improve control of biotechnology processes by meeting consensus
specification (i.e., adequate process capability)
Maintain chain of custody throughout the process lifecycle
Scope
Developing International Standards for traceable, searchable, and
interoperable data together with integrated data processing for biotechnology
and life sciences
Standardization priorities
Processed data and model formats (incl. identifiers and quality management)
Minimal reporting requirements for metadata
Workflows to create, format, describe, visualize and simulate computer models
Interfacing between data, models and their metadata
ISO/PWI 21710: Biotechnology -- Data management and publication in
microbial biological resource centers (proposed by Dr. Juncai Ma)
Preliminary Work Item
Project related to the field of microbiology
ISO TC276 WG5, PWIP-Downstream data processing and integration workflows, 2015 22
Korea’s response to
ISO/TC 276
ISO/TC 276 WG 2 Biobanks and bioresources
Comments for ISO/TC 276 biobanking guidelines (by KNRRC)
‒ Version 2 (2015.09): 29 general and technical comments + proposing two new chapters
‒ Version 5 (2016.01): 9 technical comments on reception of bioresources
‒ Version 13 (2016.03): 42 general, technical, and editorial comments
‒ Version 15 (2016.07): suggestions for common CASCO clauses
Term and definition suggestion (by Kyungsook Ahn, 2015.06)
New Work Item Proposal submission (by Hwal Suh, 2015.05)
- 49 terms & definitions (WG 1_N35)
- NWIP: Cell-based Therapy - Viable therapeutic human cells - Part 1. Glossary (WG 1_N30)
ISO/TC 276 WG 1 Terminology
24
ISO/TC 276 WG 2 Biobanks and bioresources
(cont.) ISO/PWI 21709 Biotechnology ‒ Biobanking ‒ Process requirements for
mammalian cell lines (by KNRRC, 2016.05)
‒ Based on the KNRRC’s Best Practice Guidelines for Research Resource Centers:
Vol. 15 Human & Animal Cell Lines
25
KNRRC Best Practice Guidelines for Research Resource Centers Vol. 15 Human·Animal Cell Line
Classification system for biological materials (by
KNRRC, 2016.10 at Dublin)
‒ Proposing the classification system for TC 276
‒ Co-developed with Korean Cell Line Bank
‒ Experts from China, England, Germany, Japan, and
Luxembourg joined the project group
‒ Plans to encompass various types of cell lines
PWI, WD documents examination (by Jongwon Kim)
- NWIP : Biotechnology – Cell counting – Part 1,2
- PWI : #20391 : Methods to determine a relative accuracy for cell counting approaches.
#20395 : Quality considerations for targeted nucleic acid quantification methods.
#20396 : Methods to determine the concentration of total nucleic acids.
#20397 : Methods to evaluate the quality of the massive sequencing data.
ISO/TC 276 WG 3 Analytical Methods
PWI submission (by Dukjae Oh, 2015.11)
- PWI : #00004 : Methods to isolate cells and cellular products.
ISO/TC 276 WG 4 Bioprocessing
PWI, WD documents examination (by Woonbong Kim, Korea Bioinformation
Center)
ISO/TC 276 WG 5 Data Processing and Integration
26
2017 ISO/TC 276 General Meeting
May, 8-12, 2017, Seoul, Korea
ISO TC276 WG1 N0042 ISO TC276 Meeting Prospects Tokyo
ISO TC276 General, N0108 Draft Report of 3rd meeting-Shenzhb, 2015
Photo By J.-H. Janßen - Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=21796463
October, 24-28, 2016, Dublin, Ireland
2016 ISO/TC 276 Working Group Meeting
27
Korea National Research
Resource Center
Purpose
Integrated management of core centers and RRCs to ensure the supply of Authenticated,
Customer-oriented research resources with Easy access(ACE)
Strategic planning and establishment of a standardized resource management system
Promotion of resource utilization and cooperation with domestic and international
organizations
Organization
29
Building infrastructure for scientific researches by providing research resources and
associated information
2. Standardization of resource management and RRC operation
3. Establishment of integrated information management system
Objectives
1. Strategic planning and performance management system
4. Public relations and global cooperation
Strategic planning for mid and long term development
Recording management of RRC outcomes
Providing guidelines
Training programs and workshops
DB, homepages, inventory management system
Online search, ordering and deposition
Promoting resource utilization
Building international networks and societies of RRCs
Vision
30
Developed standards of private sectors (SPS) approved by Korean Standards
Association (KSA)
• Best Practice Guidelines for Research Resource Centers
SPS-KNRRC 0001-2008 (2015)
• General terminology for research resources center -
Operations management
SPS-KNRRC 0002-6198 (2015)
Published16 KNRRC Best Practice Guidelines
Guidelines
31
Best practice for RRCs
How to use KNRRC management system (Homepage, Inventory system, DB)
Case studies on domestic biobanks & RRCs
Nagoya Protocol and biological resources
Identification, classification and preservation methods
Preparation for RRC evaluation, etc.
TOPIC
KNRRC holds workshops and education programs for KNRRC researchers 2~3 times/year.
Education
32
Managing and monitoring resource information
Constructing HQ Homepage, RRC Homepages, KNRRC Resource Inventory System and
KNRRC Outcome Management System (Registered a patent in Korea, May 2014)
Providing an integrated RRC management system
33
34
ANRRC members
2009
Beginning
104 government-funded institutes from 14 countries
• To promote cooperation and networking among Asian BRCs, KNRRC organized ad-hoc meeting for
organizing ANRRC in January 2009.
• Three institutes, RIKEN BRC (Japan), IMCAS (China) and KNRRC (Korea) signed MOU for cooperation and
launched ANRRC in September, 2009.
• http://www.anrrc.org
• KNRRC Director-General, Yeonhee Lee served as the founder president.
• KNRRC serves as a permanent secretariat of ANRRC.
• Member countries: Australia, Azerbaijan, China, India, Indonesia, Japan, Korea, Malaysia, Mongolia,
Pakistan, Philippines, Singapore, Thailand, Vietnam
Affiliate organizations
ISBER, ESBB, ISO/TC276
• Category A liaison of ISO/TC276
Thank you