Strategic Plans: Protein Analysis Working Group › ws › CCQM › CCQMSP › Allowed › 2017 ›...

Snag-Ryoul Park

Strategic Plans:

Protein Analysis Working Group

2017. 04. 26

srpak@kriss.re.kr

I. Major Achievement

1. Accomplishment of K115/P55.2 study

• Purity determination of human C- peptide

I. Major Achievement

2. Two Focus Groups Launched

• Focus Group I: Measurement Traceability

I. Major Achievement

2. Two Focus Groups Launched

Focus Group 2: Measurement Capability

II. Major Challenges

Complexity in meausrands • Enormous work and cost to establish traceability

• Relatively large uncertainty

• Large gaps between metrology and stakeholders

III. New in Strategy

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

III. New in Strategy

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

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?

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

Thank you!