Biotechnology products are the yield of engineering labors that process biological material and agents to produce a modified biological substance. Examples of biotechnology drugs are monoclonal antibodies and recombinant DNA. Monoclonal antibodies are important reagents in the treatment and diagnosis of disease. They have been used for diagnosis of pregnancy, detection of presence and concentration of drugs in the blood, histocompatibility assay, and detecting shed tumor antigens. They are antibodies that are mass produced in a laboratory from a single clone that recognizes only one epitope of a single antigen. Recombinant DNA is DNA that has been created artificially and codes for a specific desired protein for harvest. New biotechnology drug discovery begins with identification of cellular and genetic factors that play a role in specific diseases. Chemical and biological substances that target these factors are likely to have drug-like effects and are searched for. If an antigen is identified as a disease causing agent, a monoclonal antibody could be an appropriate therapeutic agent to develop. Or if a single protein is likely to exert a pharmacological effect recombinant DNA may be appropriate.
After the desired chemical substances have been identified, research for production can begin. The processes of recombinant DNA production and Monoclonal antibody production are very different. Most antigens have many antibody binding sites, or epitopes. Therefore, many different antibodies may bind to any one antigen. Monoclonal antibodies are specific for only one antigen epitope. Epitope specificity brings several advantages including dose response predictability and uniformity of batches. In 1975 Kohler and Milstein developed a process that produced monoclonal antibody.
The generation of monoclonal antibodies requires a living organism, normally, a mouse. The first step in monoclonal antibody production is immunization of mice. The
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