Unwanted immunogenicity risk in biotherapeutic discovery and development

The biotherapeutics field continues to expand and introduce both new innovative therapies, as well as biosimilar and improved versions of marketed biotherapeutics into the clinic. In this environment, risk of inducing unwanted anti-therapeutic immune responses (immunogenicity) remains a concern due to the potential to affect safe or efficacious use, or affect development costs, regulatory pathways, or competitive position in the market. Because of the potential risks to product safety and survivability, there is increasing pressure to develop improved methods to assess risk of unwanted immunogenicity and its consequences in order to inform risk mitigation strategies and business decisions. Well known factors contributing to risk for development of immunogenicity include product-, patient or disease-, and treatment regimen-related attributes. Most likely, multiple factors contribute simultaneously to overall risk. This presentation will overview the sources of risk and how incorporation of new risk assessment tools could provide more accurate assessment to improve risk mitigation