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Enzyme Immunoassays - From Concept To Product Development (Hardcover, 1996 ed.)
Loot Price: R5,499
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Enzyme Immunoassays - From Concept To Product Development (Hardcover, 1996 ed.)
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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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