holistic approach for analytical method transfer
TRANSCRIPT
© 2019 Artel1
© 2013 ARTEL
Holistic Approach for Analytical Method Transfer
Nathaniel Hentz, Ph.D.Director, Scientific Market Development
Artel, Inc.
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Key Phases in Assay AutomationPhase 1: Biology Phase 2: Automation
Method
Transfer
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Method Transfers Are CriticalMany reasons for failure
Poor documentationInsufficient communication
Improper trainingPoor equipment qualification
Weak method development/validationPoor acceptance criteria/specifications
10-40% method
transfers fail
© 2019 Artel4
© 2013 ARTEL
Method Transfers Are CriticalMany reasons for failure
Poor documentationInsufficient communication
Improper trainingPoor equipment qualification
Weak method development/validationPoor acceptance criteria/specifications
10-40% method
transfers fail
*Artel MVS can address these issues
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© 2013 ARTEL
Assay
Detector
ALH Settings
Sample
Environment
Parameters that Effect Assay VariabilityHardware /
LabwarePlate type, tip type, tubing, automation
Off-set volume, single/multi dispense, aspirate/dispense rate, aspirate/dispense height, liquid class, pre / post air gaps, etc.
PMT, wavelength, x-y-z position
Mixing, incubation time, centrifugation, # liquid transfers, wash steps, dilution steps, serial dilutions
Viscosity, density, surface tension, volatility
Temperature, humidity, light, vibration
Process
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The Problem
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The Solution
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The Result
Good Assay
0 1 2 2 4 3 6 4 8 6 0 7 2 8 4 9 60
2 0 0 0
4 0 0 0
6 0 0 0
8 0 0 0
1 0 0 0 0
W e ll ID
Sig
na
l (R
FU
)
Z’ = 0.74
Better Assay
0 1 2 2 4 3 6 4 8 6 0 7 2 8 4 9 60
2 0 0 0
4 0 0 0
6 0 0 0
8 0 0 0
1 0 0 0 0
W e ll ID
Sig
na
l (R
FU
)
Z’ = 0.94
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How is This Accomplished?
Process Optimization
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The Result
-2 -1 0 1 20
1000
2000
3000
4000
Log Inhibitor (nM)
Sign
al (
RFU
)Opt 1Opt 2Opt 3
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Value Proposition
Reduce error rates
Minimize overall
variability
Improve data resolution
Speed method transfer
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Q&A
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Thank YouWould you like more information?
1. N. Hentz and E. Avis. Improving Assay Performance Using a Process Optimization Approach; SLAS2017 poster.
2. N. Hentz and T. Knaide. Effect of Liquid-Handling Accuracy on Assay Performance; J. Lab. Automation, 2014, 19(2) 153–162.
3. http://www.artel-usa.com/resource-library/