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Assay Development and Technologies, 2nd Edition
Drug and Market Development Publishing, Sep 2006, Pages: 282


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'Assay Development & Technologies, 2nd Edition' offers essential information to speed up and simplify assay development.

This professional development guide thoroughly evaluates the capabilities, strengths, weaknesses, and expectations of leading assays and assay technologies to provide you with the information necessary to select and develop the appropriate assay for the task at hand.

The purpose of this report is to help biotechnology and pharmaceutical professionals choose and develop appropriate assays. This Second Edition includes additional content to reflect recent advancements in assay technology. A presentation of the many applications for whole cell assays as well as an expanded discussion of assay multiplexing has been added. This material recognizes the growing importance of high content, cell-based assays in drug discovery and candidate development. The section on assay methods for ion channels has also been expanded due to the emergence of analytical platforms for high-throughput screening of this very significant pharmaceutical target class. Finally, a lengthy appendix devoted to fluorescent proteins has been added that discusses the assay applications and properties of these important 'reporter' molecules.

Emphasis is on discovery and R&D stages, although these assays are also important for manufacturing and QC. This report will present information on both high-content and highthroughput assays. Because it is intended to facilitate the proper choice of assay formats, this report includes many detailed comparisons between the leading possibilities for assays.

This report also emphasizes certain, of the more common, assays in biopharma. These include specific discussions of measuring compound quantity, microbial contamination, binding, enzymes, G protein-coupled receptors (GPCRs), ion channels, toxicology-pharmacology, and genetic polymorphism. It also includes emphasis on cell-based assay formats, and the most modern assay platforms, featuring miniaturization and automation.

This report presents emerging technologies for assays from the point of view of capabilities, strengths and weaknesses, and expectations for the future. The vocabulary and style of this report assume that the reader has completed at least a bachelor level education in molecular biology, biochemistry, immunology, or a similar scientific field. Experience or familiarity with assay terminology and technologies are generally not assumed, but an understanding of the business context of the assay program is important for implementing the procedures described herein.

This report does contain some technical instructions; in order to be truly useful, many tips for troubleshooting comprise specific materials and methods, however, it is not a laboratory recipe book. Detailed laboratory procedures are mostly left to development by individual labs, in response to local assay goals, policies, and requirements.
The information contained here is intended to provide knowledge of assays and assay development that normally accumulate over many years of personal experience with laboratoryassay technology. This information does not supersede requirements imposed by the assay laboratory’s corporate, legal, or regulatory environment. While it cannot replace the judgment of experienced laboratory scientists and team managers, it should greatly assist such persons in their duties.

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