Immunogenicity Assessment of Biotherapeutic Products: An Overview of Assays and Their Utility

Wadhwa M, et al., 43(5):298-306, Biologicals, 2015

This review article elaborates on the evaluation of immunogenicity in biotherapeutic products (BTPs). In pharmaceutical industry, BTPs represent a fastest growing market. However, the immunogenicity of BTPs continues to present a challenge. In this article, the authors describe the platforms used for the evaluation of immunogenicity. The article also describes their advantages and limitations. The authors highlight high tolerance shown by the Bio-Layer Interferometry (BLI) platform (Pall ForteBio Octet) against residual therapeutics in samples.

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