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)


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/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.


May 9-13, 2016

Washington DC, U.S.A.


October 24-28, 2016

Dublin, Ireland


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


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


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

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