The immunogenicity of biologics is a significant concern, which can affect safety and efficacy. In this Spotlight we will explore recent developments in immunogenicity, highlight key challenges when reviewing immunogenicity, and explore current regulations.
Immunogenicity is the ability of a therapeutic protein to stimulate an immune response, developing antidrug antibodies to neutralize or bind the offending protein. It is an important assessment required for drug approvals that is measured and characterized. However, with the increase in biologics, how do scientists apply more sensitive and robust techniques and what challenges remain for assessing immunogenicity?
As part of this Spotlight, we will aim to cover a range of developments including:
- Techniques utilized to investigate immunogenicity
- Relationships between assay data and clinical outcome
- Regulation and standardization