How can you assess the immunogenicity of a biotechnology product?
Immunogenicity is the ability of a substance to elicit an immune response in the body. For biotechnology products, such as recombinant proteins, monoclonal antibodies, or gene therapies, immunogenicity can pose a serious risk of adverse effects, reduced efficacy, or loss of tolerance. Therefore, assessing the immunogenicity of a biotechnology product is a crucial step in the development and regulatory approval process. In this article, you will learn about the main factors that influence the immunogenicity of a biotechnology product, the methods and tools to measure it, and the strategies to mitigate it.