الفهرس 
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Abstract
Recommendations for Monoclonal Antibody Applications:
Monoclonal antibodies, following the development of hybridoma technology in 1975, have become an extraordinarily important resource for medical research, diagnosis, therapy, and basic science.
This assay presents issues associated with and recommendations on the documentation to support the use of monoclonal antibodies (mAb) reagents generated by hybridoma technology, recombinant mAb or their fragments in bacteria, including phage display technology, fungi (yeasts and molds), and transgenic animals.
This document provides recommendations on mAbs that are used as diagnostics, radio labeled imaging agents, or therapeutic products.
Most common diagnostic applications of monoclonal antibodies. Include:
1. Analysis of cell surface and secreted molecules e.g. CD molecules identification and Identification of transcription factors.
2. Immunodiagnosis of many infectious disease (bacterial, viral and fungal) e.g. diagnosis of H. pylori eradication.
3. Identification of susceptibility genes that predispose to development of autoimmune thyroid diseases.
4. Tumor diagnosise.g. Colorectal cancer
5. Molecular imaging
a. Immuno-positron emission tomography (Immuno-PET)
b. Molecular imaging of cardiovascular disease using ultrasound.
Most common Therapeutic applications of monoclonal antibodies. Include:
1. Monoclonal antibody in cancer therapy e.g. prostate cancer and renal cell carcinoma.
2. Autoimmune disease Multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus.
3. Treatment of asthma and other manifestations related to allergic diseases.
4. Prevention of transplant rejection.
5. Treatment of myocardial infarction and in coronary artery bypasses graft surgery.
6. Viral infection e.g. West Nile virus and trial for treatment of H5N1 influenza.
7. Treating eye diseases.
Absence of funding is the mam Limitation for the extensive therapeutic applications of the monoclonal antibodies.
Summary
Monoclonal antibody is an antibody that IS specific for one antigen and is produced by a B-cell hybridoma.
The process of producing monoclonal antibodies was invented by Georges Kohler and Cesar Milstein, in 1975. The key idea was to use a line of myeloma cells that had lost their ability to secrete antibodies, come up with a technique to fuse these cells with healthy antibody producing B cells, and be able to select for the successfully fused cells.
Hybridoma technology has been replaced by recombinant DNA technology and transgenic method (mice, plant and chickens).
Once monoclonal antibodies for a given substance have been produced, they can be used to detect the presence and quantity of this substance and so monoclonal antibody has many diagnostic applications.
One of these most important applications is analysis of cell surface and secreted molecules like CD molecules identification and identification of transcription factor FOXP3.
The diagnosis of many infectious diseases relies on the detection of particular antigens or antibodies in the circulation or in tissues by use of monoclonal antibodies in immunoassays, for example bacteria diseases (Chlamydiae pneumoniae, serotyping niesseria meningitides and diagnosis of H. pylori eradication 4 weeks after the end of treatment), Viral diseases (rubella virus, hepatitis E virus and SARS-CoV nucleocapsid protein) and airborne fungi.
In the field of molecular genomics the application of molecular biology with the help of monoclonal antibody has permitted identification of susceptibility genes that predispose to development of autoimmune thyroid diseases.
Also by the help of monoclonal antibody we can detecte oncofetal antigen, altered surface glcoproteins and glycolipids. And this helps in diagnosis of many cancers for example colorectal cancer and brain tumors.
And there is a very important application in the field of molecular imaging especially in Immune-positron emission tomography (Immuno¬PET). Immuno-PET combines the high sensitivity and resolution of a PET camera with the specificity of a mAb. immuno-PET enables the confirmation of tumor targeting and the quantification of mAb accumulation (in fact, radioactivity uptake). Thus, we can select patients who have the best chance to benefit from expensive mAb-based therapy.
In addition to its diagnostic applications monoclonal antibody have many therapeutic applications and one of the most important of these therapeutic applications is the use of monoclonal antibody in the treatment of cancer. In cancer treatment monoclonal antibody are used to specifically target cells. The main objective is stimulating the patient’s immune system to attack the malignant tumor cells and the prevention of tumor growth by blocking specific cell receptors. Mab are coupled with radioactive doses (Radioimmunotherapy) or lethal chemical doses and so the doses are delivered directly to the target cells.
Also Mab are used in the treatment of autimmune diseases like multiple sclerosis (MS), rheumatoid arthritis and systemic lupus erythematosus.
Anti-IgE monoclonal antibody (Omalizumab) is a nonanaphylactic synthetic antibody, represents a new class of medicine for the treatment of allergies, it is an anti-IgE antibody that acts to inhibit IgE from bonding with the high-affinity receptor on mast cells and basophils right from the initial sensitization phase of the allergic response, in addition to blocking the immunoglobulin from binding with the low-affinity receptor in B lymphocytes.
Blocking IgE with omalizumab in allergic patients with severe asthma that cannot be controlled with inhaled corticosteroids and long¬acting bronchodilators can result in detectable improvements in clinical status.
Anti- T cell monoclonal antibodies derived from mouse B cells and directed against human T cells, particularly those reacting with the CD3 marker (muromonab CD3, OKT3), have been extensively used in the management of transplanted patients.
Mab are used also in the treatment of myocardial infarction and in coronary artery bypasses graft surgery as they inhibit complement-mediated tissue damage associated with reperfusion injury and inflammation that occurs during open heart surgery.
Also Mab are used in the treatment of some viral disease like West Nile virus and H5NI influenza infection.