Therapeutic antibodies have garnered widespread attention in the biopharmaceutical industry,with promising implications for the treatment of numerous diseases. Advanced humanization techniques for therapeutic antibodies have been identified as a potential game-changer in the life sciences industry, elevating antibody candidates to a new level of prestige, with enhanced qualities such as reduced immunogenicity and superior biochemical and biophysical properties.
The humanization process involves modifying the antibody structure to make it more similar to the ones naturally produced by humans, reducing the potential for adverse immune responses when used as a therapy. With technological advancements rapidly changing the landscape of antibody engineering, humanization is becoming an increasingly attractive approach for the development of safer and more efficient therapeutic antibodies.
Since the FDA approved the first therapeutic antibody in 1986, Orthoclone OKT3, over 100 recombinant antibodies have received FDA approval. In recent years, the FDA’s approval rate for monoclonal antibody drugs has continued to increase, with a significant focus on humanized and fully humanized antibodies. In fact, all the monoclonal antibodies approved in 2021 are of human origin. This trend suggests that the market will continue to be dominated by humanized or fully humanized antibodies in the future.