LabAutomation 2006 - SLAS

TP43
Joe Palandra
Pfizer
Ann Arbor, Michigan
joe.palandra@pfizer.com
Where Laboratory Technologies Emerge and Merge
Co-Author(s)
Dave Weller
Lisa Buchholz
Pfizer PDM
Let the Robot Do the Work: Completely Automated Biological Sample Preparation
The pharmaceutical industry is in a state of constant evolution necessary to ensure long-term prosperity and survival. We are constantly
being challenged to increase efficiency and productivity while minimizing costs. The discovery bioanalytical group provides both in-vivo and
in-vitro support for ADME, pharmacology and toxicology studies primarily with the use of HPLC-MS-MS systems. Prior to sample analysis
the drug of interest must be extracted out of a sample matrix, typically plasma or urine, to a liquid suitable for the mass spectrometer
(MS). Protein precipitation, a widely recognized sample preparation method of choice for rapid method development consistent with the
discovery decision making timeline, is typically performed manually. This process is not only time consuming due to the many volumetric
transfer and processing steps involved but is also prone to human errors. Automation, with all of its efficiency gains, has had a slow uptake
in the bioanalytical discipline, especially in a discovery environment where previous instruments were not broadly applicable to the small
batches and variable matrices typically seen. The Hamilton Microlabstar, however, provides the bioanalytical chemist a more efficient and
broadly applicable technique to sample preparation. The Microlabstar is a robotic pipetting workstation capable of performing all of the
sample preparation steps prior to LC-MS-MS sample analysis using a flexible software interface. In this poster we will discuss the software
development, validation of the instrument and efficiencies gained by using the Hamilton software for sample preparation.
TP44
Marc Pfeifer
Roche Molecular Systems, Inc.
Pleasanton, California
marc.pfeifer@roche.com
Co-Author(s)
Bruno Alessandri
Roche Instrument Center AG
Chris Parkhouse
Roche Molecular Systems, Inc.
Judith Pinsl-Ober
Peter Wenzig
Roche Diagnostics GmbH
The Cobas s 401 System: High-Throughput Automation for Simultaneous Screening of
HCV, HBV and HIV Nucleic Acids in Plasma Samples
Molecular diagnostic tests for infectious diseases require RNA/DNA extraction, amplification and detection of nucleic acid targets present
in the specimen. Operator “hands-on” time, increasing testing volumes, as well as process variability and errors can be addressed by
automation. For many blood testing laboratories, however, automation alone is insufficient. Medical device regulations and a highly
controlled environment put particular emphasis on assuring system reliability and result integrity. The cobas s 401 system represents
another evolution step in the development of PCR automation as it not only fully combines sample preparation and multiplex PCR steps,
but also includes state of the art process surveillance features. Device built-in quality control measures include temperature sensing, robotic
positioning and motion control, as well as liquid flow, air-pressure-based and capacity-coupled liquid (cLLD) sensors to detect aspiration
and dispensation inaccuracies. Residual risk is addressed by chemistry in-process control that includes the use of internal control (IC), one
negative external control (NC) and five positive armored external controls (PC) used in conjunction with the cobas TaqScreen MPX assay
that can detect HIV-1 (groups M and O), HIV-2, HCV and HBV simultaneously. In addition to the Roche provided kit controls the cobas s
401 system supports running of user-defined external controls for co-validating the batch.
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