Unwanted immunogenicity: lessons learned and future challenges.

Wadhwa, M., Thorpe, R.
Journal   Bioanalysis
Analytes Measured  
Matrix Tested  
Year   2010
Volume   2
Page Numbers   1073-1084
Application   Immunogenicity
All biological therapeutics have the potential to induce an immune response in recipients of these products. Elicitation of an immune response can result in variable clinical impact, ranging from benign to severe adverse effects, a diminution in clinical efficacy or, in some cases, hypersensitivity or allergic reactions. Consequently, assessment of unwanted immunogenicity is an important element of the data required for regulatory submission for product approval. However, issues relating to immunogenicity occur throughout the life-cycle of a biotherapeutic and need to be considered appropriately when introducing any product change(s). Evaluation of immunogenicity of a product requires a well-considered strategy and a panel of appropriately validated (or 'fit-for-purpose') assays for antibody detection and characterization in clinical samples. An overview of the bioanalytical methods that are currently being used for assessment of immunogenicity of biotherapeutics and the guidance available along with some of the challenges facing the industry are discussed in this review.

View Publications
Browse Our Products

By Analytes
By Applications
Customer Service/Orders

Scientific/Technical Support

Instrument Support

Company Headquarters