LabAutomation 2006 - SLAS

LabAutomation 2006 - SLAS LabAutomation 2006 - SLAS

23.02.2013 Views

TP41 Clifford Olson Zinsser Analytic Northridge, California cliffolson@zinsserna.com LabAutomation2006 Co-Author Werner ZInsser, Zinsser Analytic Powder Dispensing – The Challenge for Automation New Technologies in Powder Dispensing Competition in chemical related markets, i.e. pharmaceuticals, agrochemicals, fine chemicals, paint development, etc. has put pressure on the development of new compounds. Speed has become a cost factor, as only the first in the market will harvest extra profits. Skilled and educated manpower for the research work is becoming a limited factor. Automation is considered the key to increase efficiency, to improve the timelines and to produce reproducible methods. Liquid handling systems have already been on the market for decades and are established in every lab. However, numerous applications also require dispensing solid samples. Still, the distribution of solid compounds has just become an issue in automation in the last few years. Dispensing powders manually is not only a time-consuming and tedious job, it may also lack precision and reproducibility. This is due to the characteristics of powders such as particle size, electrostatics as well as their behaviour when being shaken, which also poses a challenge to automating this process. There are companies with very sophisticated powder distribution techniques, but no one had automated a complete integration of powder distribution, liquid pipetting, weighing, barcode tracking, database im-/export, etc. Zinsser Analytic had addressed this issue already a few years ago and has gained expertise in dispensing solid compounds. Now, we have developed new technology for precise distribution of difficult powders ranging from 1µl to 2000µl volume which could not be automated before. With this new developed technology we can achieve a CV of 3% for 1mg depending on the powder properties. TP42 Tom Onofrey Nanostream Pasadena, California nilma.rubin@nanostream.com Co-Author Paren Patel Nanostream, Inc. Parallel Liquid chromatography to increase throughput for ADME and DMPK studies Demand for ADME profiling has increased in early stages of drug discovery (i.e., in lead optimization) as well as in downstream areas closer to the clinic (i.e., drug metabolism). The increase in demand has resulted in the proliferation of instrumentation and techniques aimed at the characterization of various physiochemical properties and the need for software solutions to extract meaningful results from increasing amounts of data and types of data formats. Recent advances in high-throughput liquid chromatography systems and in analysis software have reduced the total amount of time associated with characterization of ADME properties such as log P/log D, solubility, and permeability—all using a familiar and standardized platform. The increase in analytical throughput has also allowed researchers in drug metabolism to overcome LC and sample preparation constraints associated DMPK assays (e.g., drug drug interaction studies) performed using MS/MS. Examples will be shown to demonstrate how these strategies can be used to accelerate ADME assays conducted at the lead optimization and pre-clinical stages of drug discovery. 172

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. 173

TP41<br />

Clifford Olson<br />

Zinsser Analytic<br />

Northridge, California<br />

cliffolson@zinsserna.com<br />

<strong>LabAutomation</strong><strong>2006</strong><br />

Co-Author<br />

Werner ZInsser, Zinsser Analytic<br />

Powder Dispensing – The Challenge for Automation New Technologies in<br />

Powder Dispensing<br />

Competition in chemical related markets, i.e. pharmaceuticals, agrochemicals, fine chemicals, paint development, etc. has put pressure on<br />

the development of new compounds. Speed has become a cost factor, as only the first in the market will harvest extra profits. Skilled and<br />

educated manpower for the research work is becoming a limited factor. Automation is considered the key to increase efficiency, to improve<br />

the timelines and to produce reproducible methods. Liquid handling systems have already been on the market for decades and are<br />

established in every lab. However, numerous applications also require dispensing solid samples. Still, the distribution of solid compounds<br />

has just become an issue in automation in the last few years.<br />

Dispensing powders manually is not only a time-consuming and tedious job, it may also lack precision and reproducibility. This is due to the<br />

characteristics of powders such as particle size, electrostatics as well as their behaviour when being shaken, which also poses a challenge<br />

to automating this process. There are companies with very sophisticated powder distribution techniques, but no one had automated a<br />

complete integration of powder distribution, liquid pipetting, weighing, barcode tracking, database im-/export, etc. Zinsser Analytic had<br />

addressed this issue already a few years ago and has gained expertise in dispensing solid compounds. Now, we have developed new<br />

technology for precise distribution of difficult powders ranging from 1µl to 2000µl volume which could not be automated before. With this<br />

new developed technology we can achieve a CV of 3% for 1mg depending on the powder properties.<br />

TP42<br />

Tom Onofrey<br />

Nanostream<br />

Pasadena, California<br />

nilma.rubin@nanostream.com<br />

Co-Author<br />

Paren Patel<br />

Nanostream, Inc.<br />

Parallel Liquid chromatography to increase throughput for ADME and DMPK studies<br />

Demand for ADME profiling has increased in early stages of drug discovery (i.e., in lead optimization) as well as in downstream areas<br />

closer to the clinic (i.e., drug metabolism). The increase in demand has resulted in the proliferation of instrumentation and techniques<br />

aimed at the characterization of various physiochemical properties and the need for software solutions to extract meaningful results from<br />

increasing amounts of data and types of data formats. Recent advances in high-throughput liquid chromatography systems and in analysis<br />

software have reduced the total amount of time associated with characterization of ADME properties such as log P/log D, solubility, and<br />

permeability—all using a familiar and standardized platform. The increase in analytical throughput has also allowed researchers in drug<br />

metabolism to overcome LC and sample preparation constraints associated DMPK assays (e.g., drug drug interaction studies) performed<br />

using MS/MS. Examples will be shown to demonstrate how these strategies can be used to accelerate ADME assays conducted at the<br />

lead optimization and pre-clinical stages of drug discovery.<br />

172

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