Product immunogenicity can result in development of anti-drug antibodies (ADAs) that can enhance clearance of biotherapeutics, reduce their efficacy or evoke safety issues that may limit the population that benefits from treatment or result in clinical stage failure of a development program. While animal models are not predictive of immunogenicity, NAMs (In silico and in vitro analytical methods) may be used to identify and characterize product attributes that need to be controlled to reduce the immunogenicity risk and help streamline the development of new molecular entities as well as generic peptides and biosimilars. This talk will discuss available and emerging approaches, data interpretation, and remaining knowledge gaps in the application of NAMS to immunogenicity.
Learning Objectives:
Understand potential applications of NAMs to immunogenicity risk assessments
Learn about the potental impact of IIRMI to immunogenicity risk
