| Enzyme Immunoassays: From Concept to Product Development 1996 Edition Contributor(s): Deshpande, S. S. (Author) |
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ISBN: 0412056011 ISBN-13: 9780412056017 Publisher: Springer OUR PRICE: $208.99 Product Type: Hardcover - Other Formats Published: June 1996 Annotation: 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. |
| Additional Information |
| BISAC Categories: - Science | Chemistry - Clinical - Science | Chemistry - Analytic - Medical | Diagnosis |
| Dewey: 616.075 |
| LCCN: 95032913 |
| Physical Information: 1.3" H x 6.38" W x 9.5" (1.92 lbs) 464 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: Since the classical work of Rosalyn Yalow and Solomon Berson on the radioim- munoassay of insulin in the late 1950s, which so brilliantly opened new domains in the diagnostics sector, immunoassays have been well received as a diagnostic and research tool in several disciplines of life sciences. The economics, rapidity, sensitivity, specificity, and the easy-to-use approach of immunodiagnostic tests are widely recognized, and have had a tremendous impact on clinical, agricultural, food, veterinary, and environmental diagnostics. At present, in the clinical diag- nostic sector alone, immunoassay products command an annual worldwide mar- ket value in excess of U. S. $10 billion, which is expanding by about 10% per annum. The recent trend toward increasing demand for automation of immunoassays and stable reagents clearly shows a definitive shift to nonisotopic immunoassay systems on a large scale. Historically, enzyme immunoassays have been in a prime position for in-house applications, primarily because of the easy access to inex- pensive measuring equipment as well as to a vast body of literature on labeling techniques and applications. The recent popularity with the general public of sev- eral over-the-counter immunoassay products based on this technology, such as glucose level kits for diabetics, cholesterol screening tests, and pregnancy detec- tion test kits, is quite evident. |