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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

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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

*Artel MVS can address these issues

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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/