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Snag-Ryoul Park Strategic Plans: Protein Analysis Working Group 2017. 04. 26 [email protected]

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Page 1: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

Snag-Ryoul Park

Strategic Plans:

Protein Analysis Working Group

2017. 04. 26

[email protected]

Page 2: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

I. Major Achievement

1. Accomplishment of K115/P55.2 study

• Purity determination of human C- peptide

Page 3: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

I. Major Achievement

2. Two Focus Groups Launched

• Focus Group I: Measurement Traceability

Page 4: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

I. Major Achievement

2. Two Focus Groups Launched

Focus Group 2: Measurement Capability

Page 5: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

II. Major Challenges

Complexity in meausrands • Enormous work and cost to establish traceability

• Relatively large uncertainty

• Large gaps between metrology and stakeholders

Page 6: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

III. New in Strategy

The 3rd Focus Group (Metrology for Protein Biologics)? • To catch up high impact protein biologics industry

Page 7: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

III. New in Strategy

The 3rd Focus Group (Metrology for Protein Biologics)? • A tremendous set of analytical methods applied

Page 8: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

III. New in Strategy

The 3rd Focus Group (Metrology for Protein Biologics)? • To catch up high impact protein biologics industry

Metrological Soundness

Imp

act

Purity assessment

Measurement of matrix samples

Structure analysis

FG1

FG2

FG3?

Page 9: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

IV. Planned comparisons

One comparison for each focus group a year

FG-activ.

2016K115/p55.2 P137

2017

P164-I

Insluin

2018

preparation

Oxytosin P164-II execution

GE/VE result report

2019

Tot Hb BNP

Hb A1c

2020

2021 PTH

CCQM PAWG Study schedule (2017-spring)

FG1 FG2

Page 10: Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 › WS2017-11_… · 2017-05-17 · Strategic Plans: Protein Analysis Working Group

Thank you!