Polyclonal immunoglobulin (Ig) preparations have been used for several decades for treatment of primary and secondary immunodeficiencies and for treatment of some infections and intoxications. This has demonstrated the importance of Igs, also called antibodies (Abs) for prevention and elimination of infections. Moreover, elucidation of the structure and functions of Abs has suggested that they might be useful for targeted treatment of several diseases, including cancers and autoimmune diseases. The development of technologies for production of specific monoclonal Abs (MAbs) in large amounts has led to the production of highly effective therapeutic antibodies (TAbs), a collective term for MAbs (MAbs) with demonstrated clinical efficacy in one or more diseases. The number of approved TAbs is currently around hundred, and an even larger number is under development, including several engineered and modified Ab formats. The use of TAbs has provided new treatment options for many severe diseases, but prediction of clinical effect is difficult, and many patients eventually lose effect, possibly due to development of Abs to the TAbs or to other reasons. The therapeutic efficacy of TAbs can be ascribed to one or more effects, including binding and neutralization of targets, direct cytotoxicity, Ab-dependent complement-dependent cytotoxicity, Ab-dependent cellular cytotoxicity or others. The therapeutic options for TAbs have been expanded by development of several new formats of TAbs, including bispecific Abs, single domain Abs, TAb-drug conjugates, and the use of TAbs for targeted activation of immune cells. Most promisingly, current research and development can be expected to increase the number of clinical conditions, which may benefit from TAbs.
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