Translational Medicine

Development and Validation of Cell-Based Neutralizing Anti-Adalimumab Antibody Detection Methods for Adalimumab Biosimilar Program - August, 2014

Adalimumab (Humira™) is a genetically engineered, fully humanized monoclonal antibody that binds TNF-α, preventing it from activating TNF-α receptor. The drug has been approved for rheumatoid arthritis, psoriatic arthritis and Crohn's disease in the United States. Due to this wide-ranging therapeutic value, PF-06410293 is being developed as a potential biosimilar to Adalimumab. We have developed and validated two cell-based assays for the detection of either anti-Adalimumab innovator or anti-PF-06410293 antibodies in human serum, to support ongoing clinical studies.

In this poster, we present two cell based assays QPS and Pfizer have developed and validated for the detection of either anti-Adalimumab innovator or anti-PF-06410293 antibodies in human serum, in support of ongoing clinical studies.

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