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Presentation (Pharmaceutical Dosage Form Track):  Ion Mobility Spectrometry: A Fast, Sensitive and Robust HPLC Alternative

Laboratories and production facilities now have an alternative to HPLC that can provide important advantages in speed, sensitivity and robustness.The new method utilizes a technology called ion mobility spectrometry (IMS) that is similar to mass spectrometry. IMS has the advantage that it can determine the presence or absence of an organic chemical in seconds with virtually no learning curve for the user. Because of its speed, small footprint and low detection limits, thousands of IMS instruments are now in use for detecting explosives, illicit drugs, and chemical warfare agents. More recently, IMS has begun moving into the laboratory based on advantages such as being able to analyze a typical sample in under 30 seconds compared to 30 to 90 minutes for HPLC.The sensitivity of IMS also compares very favorably to HPLC - it can detect quantities from 0.1-10 nanograms of most pharmaceutical compounds.Typical laboratory applications include cleaning verification, quality control and chemical monitoring. If the application requires quantifying or identifying very low concentrations, IMS is likely the most effective technique.

Presentation (Pharmaceutical Dosage Form Track):  Application of the Sotax AT70smart within a development laboratory
Donal J. Murphy,  Astrazeneca

In the pharmaceutical industry, Good Manufacturing Practice (GMP) guidelines require careful validation of automated processes so that fitness for purpose can be demonstrated. This is also true of automated dissolution where validation must be performed for each of the products to be tested to ensure reproducible and robust method operation. Key validation considerations are discussed including some which are specific to the Sotax AT70smart. Experiences with the Sotax AT70smart and its application within a development laboratory are also discussed.

Presentation (Pharmaceutical Dosage Form Track):  Taste Measurement Using the E-Tongue
Ruben Lozano, Analytical R&D; Pankaj A. Shah, Analytical R&D; Manoj Nerurkar; Pharmaceutics R&D; Bristol-Myers Squibb
Sandrine Isz, Alpha MOS, Toulouse, France

Many active pharmaceutical ingredients can impart an unpleasant taste or odor, usually associated with bitterness. To produce a desirable oral drug product, especially if destined for pediatric use, development efforts focus on masking the unpleasant taste/odor, often by adding flavoring or sweetening agents to the formulation. Organoleptic analysis of such prototype products is commonly performed by human taste panels. However, in an effort to eliminate human testing due to the safety risks, alternative analytical means are being sought. The novel lectronic tongue?technology is being utilized by the food/beverage and pharmaceutical industries to evaluate product taste characteristics. It provides relative measurements of nonvolatile or low-volatile molecules and dissolved organic compounds that are responsible for taste and flavor sensations. Results of such taste evaluations are presented here from analyses using the Alpha MOS Astree E-tongue. For example, prototype developmental formulations of a liquid drug product containing different levels and combinations of sucrose, aspartame, and a flavor component (bubble gum or cherry) were analyzed. Fingerprint patterns of the samples and eference? chemicals were obtained by the E-tongue. Using Principal Component Analysis, a relative weetness index?was established, allowing comparisons among the prototype formulations and conclusions about effects of the added flavor excipients on taste characteristics. The E-tongue technology offers the potential to provide taste evaluation during formulation development or to be used as a quality-control tool, and thus significantly reduce the amount of human testing.

Presentation (Pharmaceutical Dosage Form Track):  The Delphian Rainbow Dynamic Dissolution Monitor?System
Mark Sackler, Delphian Technology

This analytical instrument is powered by a proprietary software package called Rainbow Dissolution SmartWare?and provides real-time readings of therapeutic release levels of pharmaceutical dosage forms. The system simplifies the entire dissolution testing procedure, dramatically reducing time-to-completion, lowering material costs, eliminating chemical waste, and complying with FDA mandated 21 CFR Part 11.

Presentation (Informatics Track):  The Way of XML -- Saving time and increasing reliability with XML
Liam Quin, W3C XML Activity Lead, [email protected], http://www.w3.org/People/Quin/

The Extensible Markup Language (XML) has seen widespread use in industry, in government, in research, and seems still to be spreading. Its popularity lies partly in the fact that it's a relatively simple and open specification, freely downloadable; partly in the fact that it is an intuitive way to represent structured information; and partly in the fact that every new XML document and every new XML tool multiplies the usefulness of every other XML document and tool, through interoperability.

Liam Quin is XML Activity Lead at the World Wide Web Consortium, the organization that publishes and maintains the XML Specification. He will give a brief philosophical background to XML, show some ways in which use of XML can give unexpected benefits, and give an overview into how some XML specifications fit together.

Liam will also be available to answer technical XML-related questions.

Presentation (Informatics Track):  Grid Computing
Manish Parashar, Professor, Dept. of Electrical & Computer Engineering, Rutgers University

The Grid is rapidly emerging as the dominant paradigm for wide area distributed computing. Its goal is to provide a service-oriented infrastructure that leverages standardized protocols and services to enable pervasive access to, and coordinated sharing of geographically distributed hardware, software, and information resources. Grid technologies and solutions are being rapidly developed and deployed by industry and academia and form the basis of the new national (and possibly global) Cyberinfrastructure, and are enabling a new generation of applications that are based on seamless and secure aggregations and interactions. In this talk I will introduce the vision of the Grid, and highlight key underlying technologies, emerging standards, current deployments, and open research issues/challenges.

Presentation (Informatics Track):  The Programming Language Selection Process
Steven L. Hoffman, Bristol-Myers Squibb Company

Once the decision to build custom software has been made, the next most complex task is choosing the right development platform and/or programming language. This process is often clouded by developer preferences, corporate standards, and a rapidly changing technology base. This talk will briefly describe some of the common laboratory programming environments and some of the issues that usually arise in the selection process. Then, the four currently available versions of Visual Basic (VB Script, VBA, VB6, and VB.Net) will be used to focus the discussion to feature comparisons. As each instance of Visual Basic is discussed, specific BMS applications will be used as examples of real-world laboratory applications

Presentation (Informatics Track):   Implementing a Fully Integrated Laboratory Automation and Informatics System Utilizing XML Based Messaging
Marc Feiglin (Tecan Group AG. M鄚nedorf, Switzerland), Michael Laab, Stefan T闣?(Tecan- Software Competency Center GmbH. Mainz-Kastel, Germany), Michael Laab, Stefan T闣?(Tecan- Software Competency Center GmbH. Mainz-Kastel, Germany), Jamie Bellamy, Keith Beamish, Jack Elands (IDBS. Guildford, UK) Jeff Hurwitz (Tecan-US. Research Triangle Park, NC)

With the general acceptance of automated systems throughout the research laboratory, and the associated increase in sample throughput there is an emerging need to tightly integrate the automation system into corporate informatics systems. Such integration is critical to providing the necessary audit trails for guaranteeing high quality, reliable data. This functionality requires the ability of the automation control system to be able to work with the other software systems. Previously such functionality was often provided through custom solutions developed as part of the automation control software. A better solution is to utilize an open architecture incorporating messaging technology that utilizes open standards such as XML. With messaging, a single driver can be designed for managing data messages rather than writing a separate software driver for each generator of data.

Recently, Tecan and IDBS have entered a collaboration to develop an out of the box solution that provides full integration of Tecan automation systems with IDBS' informatics solutions. This solution utilizes the XML based messaging technology introduced in version 5 of Tecan's FACTS software for automation control and IDBS' IDBS ActivityBase data management software suite. FACTS messaging is based upon proven technology from Microsoft and natively supports messaging between applications on the same computer and across computers on a corporate network. We will present the IDBS-Tecan collaboration as a case study of how XML and messaging can be utilized to provide an out-of-the box solution for a fully integrated laboratory automation and informatics system.

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