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Books > Medicine > Clinical & internal medicine > Diseases & disorders > Immunology
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From Clone to Clinic (Paperback, Softcover reprint of the original 1st ed. 1990)
Loot Price: R2,904
Discovery Miles 29 040
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From Clone to Clinic (Paperback, Softcover reprint of the original 1st ed. 1990)
Series: Developments in Biotherapy, 1
Expected to ship within 10 - 15 working days
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This book contains a selection of the papers presented at the
meeting "Between Clone and Clinic" which was organised in March
1990 in Amsterdam by the dutch Organisation for Applied Research,
TNO, and the University of Utrecht. The scope of this meeting was
the development of biotechnological pharmaceuticals mainly made by
recombinant DNA technology or monoclonal antibody techniques. All
aspects concerning the development of the products after host cells
producing them are obtained where discussed. The meeting was
attended by twohundred specialists from all over the globe,
including phar macologists, toxicologists, registration experts,
Quality Assurence managers, production en gineers and physicians.
Biotechnological pharmaceuticals are in general large and complex
protein molecules. Bringing these products to the market poses
other problems than encountered with the classical chemical drugs.
The source of biotechnological pharmaceuticals are living cells.
The function of cells are depend ent on many factors and the
stability of production may be a problem. Good Laboratory and
Manufactory Practices with Quality Control (GLP and GMP) are of
paramount importance and are discussed in a number of papers. The
products of the new biotechnology are often highly specific and
only active in the human species. Also the side effects can only be
studied in the clinical setting. Even when the product is active in
animals there is the problem of antigenicity. During treatment the
animals will produce antibodies which neutralise the activity. So
safety testing may prove difficult."
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