Immunogenicity: Meeting The Safety Reporting Requirements

Immune responses toward therapeutic proteins may cause significant adverse effects, such as loss of efficacy, hypersensitivity and autoimmunity. For that reason, it is imperative to assess the potential of therapeutic proteins along and beyond the pre-clinical and clinical development phases. In consequence, an increasing body of evidence is created along the product's life cycle, encompassing multiple and diverse aspects of its immunogenicity potential.

These accumulating data typically become more complex as time goes by, since they stem from different sources and studies. Therefore, in order to be clinically meaningful, they must be assessed in a comprehensive and integrated manner.