In this feature we will be discovering more about the topic of immunogenicity. The immunogenicity of biologics is a significant concern which can affect safety and efficacy. This series will explore what immunogenicity is, why it is important and how is it regulated and standardized. Leading immunogenicity experts will also be discussing the methods they use in identifying the immunogenicity of protein-based therapeutics, addressing recent developments, benefits and challenges of the techniques used.
Keep checking this page of the latest articles, interviews and opinion pieces.
In this article, Eric Wakshull (Genentech) describes the nature of the immune response to protein therapeutics, their clinical relevance, methodology for measuring it and approaches to interpreting the data.
In this interview, Mohsen Rajabi (FDA) discusses the process of FDA approval, why immunogenicity assays are so important and what he believes the future may hold for immunogenicity testing.
Weiping Shao discusses biomarkers, immunogenicity and the work he contributes to at Regeneron Pharmaceuticals (NY,USA).