The use of immunogenicity risk assessment tools for lead optimization of biologics

The field of Immunogenicity Risk Assessment has blossomed of late in the pharmaceutical industry. In silico and in vitro analysis for immunogenicity risk is now a standard practice at Bristol Myers Squibb. Here, we describe the various tools that we use and detail case studies where these tools were used to identify lead candidates or help to deimmunize lead candidates when significant risk was identified.