strategic plans: protein analysis working group › ws › ccqm › ccqmsp › allowed › 2017 ›...
TRANSCRIPT
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I. Major Achievement
1. Accomplishment of K115/P55.2 study
• Purity determination of human C- peptide
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I. Major Achievement
2. Two Focus Groups Launched
• Focus Group I: Measurement Traceability
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I. Major Achievement
2. Two Focus Groups Launched
Focus Group 2: Measurement Capability
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II. Major Challenges
Complexity in meausrands • Enormous work and cost to establish traceability
• Relatively large uncertainty
• Large gaps between metrology and stakeholders
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III. New in Strategy
The 3rd Focus Group (Metrology for Protein Biologics)? • To catch up high impact protein biologics industry
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III. New in Strategy
The 3rd Focus Group (Metrology for Protein Biologics)? • A tremendous set of analytical methods applied
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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?
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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
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Thank you!