Humanization and Reformatting of Therapeutic Antibody Candidates

Humanization is a well-established and standard technique for converting rodent derived monoclonal antibodies into a safe and tolerable form for therapeutic use. Although the first humanized antibody was approved by the FDA over 25 years ago, there are still many challenges and limitations to the process. Additionally, transgenic animals producing human and human-chimeric antibodies have enabled a new paradigm of candidate generation. Case studies will be presented to highlight recent developments in humanization and reformatting that leverage in silico modeling techniques and deep learning, as well as advances in expression and characterization tools, that are making the process more efficient and robust.