Humanised Antibody

Humanised Antibody designates engineered therapeutic antibodies combining complementarity-determining regions from non-human sources, typically mouse, with human framework regions and constant domains, reducing immunogenicity while retaining antigen-binding specificity. This protein engineering approach addresses limitations of mouse monoclonal antibodies that trigger human anti-mouse antibody responses limiting therapeutic utility.

The biopharmaceutical industry developed humanised antibodies as the second-generation therapeutic antibody format, with numerous products achieving blockbuster status treating cancer and autoimmune diseases. Design strategies include CDR grafting transferring only complementarity-determining regions, with framework mutations sometimes required restoring binding affinity. Computational modelling guides design predicting structures and identifying critical residues. Immunogenicity assessment evaluates anti-drug antibody formation in preclinical and clinical studies. Market success of humanised antibodies including trastuzumab and bevacizumab validated this approach and established therapeutic antibody utility. The humanised antibody legacy includes demonstrating feasibility of modifying immunogenicity through rational protein engineering.