BIOTECHNOLOGY DERIVED PRODUCTS

BIOTECHNOLOGY DERIVED PRODUCTS - BIOTECHNOLOGY DERIVED...

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1 BIOTECHNOLOGY DERIVED PRODUCTS – SAFETY EVALUATION Dr. V. JAGADEESAN 1. General and Applied Toxicology 2. Comprehensive Toxicology
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2 BIOTECHNOLOGY Refers to Techniques that change living organisms or components of these organisms to create or to improve molecules for specific use . In other words, APPLIED GENETICS is basically the technology that involves the ability to manipulate, modify or otherwise “engineer” genetic material. It was made possible by the discovery of Endonucleases or Restriction Enzymes and their ability to segments of DNA. BioTechnology: Hormone Substances Therapeutic Agents Nutritional Supplements Improves Food Supplies New Diagnostic tests Vaccines
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3 SELECTED EVENTS IN BIO- PHARMACEUTICS - Partial list Year (approx) Milepost 1940 Commercial Production of antibiotics 1953 DNA Double Helix (Structure discovery) 1967 Genetically Engineered Food Introduction (Potato) 1970 Discovery of Restriction Enzyme. 1975 Discovery of Monoclonal Hb (Hybridoma) 1976 First Commercial Company founded to develop rDNA 1978 Insulin produced by rDNA 1979 1980 Transgenic animals produced (mouse) 1982 Recombinant Animal vaccine 1983 PCR 1990 Clinical trials of human gene therapy 1993 rDNA Erythropoietin 1996 Cloning of adult mammal 1997 Plasmid DNA vaccine
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4 TRANSGENE TECHNOLOGIES “Designer Mouse” ( Transgenic Mice ) used to study immune deficiencies, cancer and developmental biology . Transgenic mice produced by inserting a foreign gene into an embryo, with this foreign gene subsequently becoming an integral part of the host animal’s genetic material. (Technique : Microinjection of DNA into pronucleus , retroviral infection , embryonic stem cells grown in vitro from explanted blastocysts ) Transgenic animal models and Genetically altered species are useful in understanding These models are important in PCT evaluation of new biotherapeutics. Basic biochemical processes Genetic diseases Effects of continuous high levels of cytokines like IL2, IL3, CSF & Erythropoietin
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5 BIOPHARMACEUTICS AND CLINICAL INDICATIONS Generic Name Trade Name Classification Indications Epoetin alpha (EPO) Epogen
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This note was uploaded on 10/07/2010 for the course DBT 456 taught by Professor Ss during the Spring '10 term at Indian Institute of Technology, Guwahati.

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BIOTECHNOLOGY DERIVED PRODUCTS - BIOTECHNOLOGY DERIVED...

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