Humanized antibody

Humanized antibodies are antibodies from non-human species whose protein sequences have been modified to increase their similarity to antibody variants produced naturally in humans. The process of "humanization" is usually applied to monoclonal antibodies developed for administration to humans (for example, antibodies developed as anti-cancer drugs). Humanization can be necessary when the process of developing a specific antibody involves generation in a non-human immune system (such as that in mice). The protein sequences of antibodies produced in this way are partially distinct from homologous antibodies occurring naturally in humans, and are therefore potentially immunogenic when administered to human patients (see also Human anti-mouse antibody). Until 2021, the International Nonproprietary Names for new humanized antibodies ended in -zumab, as in omalizumab, but a new nomenclature has since been adopted, and new names now end in different stems (see Nomenclature of monoclonal antibodies).

Humanized antibodies are distinct from chimeric antibodies. The latter also have their protein sequences made more similar to human antibodies, but carry a larger stretch of non-human protein.

There are other ways to develop monoclonal antibodies. This list covers many of the monoclonals developed for use in humans.

Use of recombinant DNA in humanization process

The humanization process takes advantage of the fact that production of monoclonal antibodies can be accomplished using recombinant DNA to create constructs capable of expression in mammalian cell culture.