FDA EMA immunogenicity guidelines APR2020

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For more information, log on to- • http://shomusbiology.weebly.com/ • Download the study materials here- • http://shomusbiology.weebly.com/bio-m... • Source of all articles published in description is Wikipedia. Thanks to original content developers. • Link- http://en.wikipedia.org/wiki/Main_Page • Source: Dr. Lopamudra Roy • Tumor antigen is an antigenic substance produced in tumor cells, i.e., it triggers an immune response in the host. Tumor antigens are useful in identifying tumor cells and are potential candidates for use in cancer therapy. • Normal proteins in the body are not antigenic because of self-tolerance, a process in which self-reacting cytotoxic T lymphocytes (CTLs) and autoantibody-producing B lymphocytes are culled centrally in primary lymphatic tissue (BM) and peripherally in secondary lymphatic tissue (mostly thymus for T-cells and spleen/lymph nodes for B cells). Thus any protein that is not exposed to the immune system triggers an immune response. This may include normal proteins that are well sequestered from the immune system, proteins that are normally produced in extremely small quantities, proteins that are normally produced only in certain stages of development, or proteins whose structure is modified due to mutation. • Initially tumor antigens were broadly classified into two categories based on their pattern of expression: Tumor-Specific Antigens (TSA), which are present only on tumor cells and not on any other cell and Tumor-Associated Antigens (TAA), which are present on some tumor cells and also some normal cells. • This classification, however,is imperfect because many antigens thought to be tumor-specific turned out to be expressed on some normal cells as well. The modern classification of tumor antigens is based on their molecular structure and source. • Accordingly they can be classified as;[citation needed] • Products of Mutated Oncogenes and Tumor Suppressor Genes • Products of Other Mutated Genes • Overexpressed or Aberrantly Expressed Cellular Proteins • Tumor Antigens Produced by Oncogenic Viruses • Oncofetal Antigens • Altered Cell Surface Glycolipids and Glycoproteins • Cell Type-Specific Differentiation Antigens

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