Currently, >60 TMAbs have been approved for clinical use. A mouse monoclonal antibody, it targeted the CD3 receptor on T cells and was used to treat acute organ rejection in transplant recipients. The first of these agents, muromonab-CD3 (Orthoclone OKT3 ®), was approved by the US Food and Drug Administration (FDA) in 1986. In parallel, the use of therapeutic monoclonal antibodies (TMAbs) was proceeding. Additional improvements in manufacturing, such as producing Fab fragments only and developing chimeric antibodies, offered further enhancements to our analytic armamentarium. For clinical chemistry, these monoclonal proteins enhanced the quality of immunoassays. In the early 1980s, using hybridoma technology (the developers of which later earned a Nobel prize), diagnostics and pharmaceutical companies began to manufacture monoclonal antibodies. Whichever diagnosis was made, ongoing monitoring of the protein concentration using SPEP was indicated. Based on the presence of other clinical and laboratory findings, some patients were diagnosed with multiple myeloma or other diseases, but the overwhelming majority of patients received a diagnosis of monoclonal gammopathy of undetermined significance. ![]() Detection and identification of these antibodies typically required serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFX). Monoclonal proteins, protein electrophoresis, immunofixation electrophoresis, MALDI-TOF, mass spectrometryīack in the day, the term M-protein, short for monoclonal protein, had one meaning in laboratory medicine: the accumulation of significant concentrations of the immunoglobulin product of a pathologic clone of plasma cells.
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