strategic plans: protein analysis working group › ws › ccqm › ccqmsp › allowed › 2017 ›...
TRANSCRIPT
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!