omation mbers - Society for Laboratory Automation and Screening

2:30 pm Thursday, February 5 Emerging Technologies – Performance Metrics Room A1
Paul Taylor
Boehringer Ingelheim
175 Briar Ridge Road
Ridgefield, Connecticut 06877
ptaylor2@rdg.boehringer-ingelheim.com
Application of Integrated Statistical Design and Analysis to Automated Assay
Optimization (AAO)
142
Co-Author(s)
Jeff Yingling, Mohammed Kashem,
Richard Nelson, Carol Homon
In the last several years high throughput screening has become a sophisticated automated environment capable
of processing tens of thousands of samples per day. In this context bottlenecks have shifted from screening
production to other areas including assay development. Statistically designed experiments have been in use since
the pioneering work of Sir Ronald A. Fisher in the 1920s. Their application to the optimization of biological assays
has, however, been limited due to the sheer number of factors and the complexity of their responses. Intricate
interactions and non-linear behaviors are a common hallmark of biological systems and this has suggested
multivariate experimental design and analysis as a useful development tool. It is only within the last several years
that the capability of translating randomized statistical designs into robotic protocols has become feasible. As
such, automation has opened the door to novel means of experimentation that would be impossible to carry
out manually due to time limitations and design complexity. Initially, simpler fractional factorial experiments were
reported as being effective and this has led to the present aim of incorporating response surface design and
predictive modeling. The attractiveness of this approach is that it allows statistical analyses to identify optima that
are distinct from experimental test conditions.
3:00 pm Thursday, February 5 Emerging Technologies – Performance Metrics Room A1
Peter Grandsard
Amgen, Inc.
One Amgen Drive
Thousand Oaks, California 91320
peterg@amgen.com
Building Confidence in Automation
Co-Author(s)
John Alexander
Henry Schultz
To get information on equipment performance levels, several Amgen’s automation users perform standardized
tests at regular intervals with results instantaneously recovered, analyzed statistically and stored in a database.
When these tests reveal problems or nonconforming performance, users and automation specialists are alerted
by e-mail and the appropriate repairs or modifications take place. This program is one way of generating and
maintaining confidence in automated systems. Other methodologies for generating that necessary level of
confidence rely on well-defined initial validations, operational procedures, roles and responsibilities, or make use of
the corporate web portal. They will be described using a small set of case studies in the areas of small molecule
storage and retrieval, high throughput screening, and pharmaceutics.