Humanization of Monoclonal Antibodies for Reduced Immunogenicity
Humanization of monoclonal antibodies (mAbs) is a critical step in minimizing immunogenic responses when these biologics are administered to patients. Originally derived from non-human sources, early mAbs often triggered immune reactions, limiting their clinical utility. Advances in humanization techniques have significantly improved safety and efficacy, boosting the Antibody Drug Discovery Market and expanding therapeutic applications.
Humanization involves replacing most of the non-human antibody sequence with human equivalents while retaining the antigen-binding regions. This reduces the likelihood of recognition as foreign by the patient’s immune system, improving tolerability and extending treatment duration.
Techniques such as CDR grafting, framework shuffling, and transgenic animal platforms enable precise humanization without compromising binding specificity or affinity. Computational tools now assist in predicting which modifications will achieve optimal balance between immunogenicity reduction and functional preservation.
With the growth of biologics pipelines, humanization is increasingly applied early in the discovery process, ensuring that candidates entering clinical trials are already optimized for patient compatibility. Combined with advances in manufacturing and formulation, humanized antibodies now form the backbone of many blockbuster therapeutics across oncology, autoimmune disorders, and infectious diseases.