Development Product Description
This unique reference provides a pragmatic approach to the development of successful commercial immunodiagnostic products based on enzyme immunoassay technology. Presenting both basic and applied principles, Enzyme Immunoassays gathers information on all aspects of this process, from the initial conceptualization to the introduction of the product to the market. Skillfully organized into two parts, this comprehensive resource begins by discussing basic concepts, such as the classification, structure and function of antibodies and the properties and characteristics of the most widely used enzymes in immunoassays. The second section examines the industrial product development process, including a detailed outline of various protocols and points to be considered for designing a successful product. Described in this section are the various formats available for product development, reagent formatting and assay development, data processing, standardization, scale up, and commercial manufacture of the product. Also included are the various regulatory requirements, the importance of good laboratory and manufacturing (GLP and GMP) practices, and international requirements such as the ISO 9000 certification process. Finally, information is presented for the benefit of entrepreneurs who would like to venture into this exciting field with their own company. With over 75 illustrations and 40 tables, Enzyme Immunoassays is an incomparable reference for scientists, technologists, and analytical chemists working in the field of immunodiagnostics at all levels, as well as for upper-level undergraduate and graduate students in life sciences fields in order to understand the basic concepts and principlesinvolved in developing rapid assay techniques.
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Development
