Testing immunogenicity of recombinant antibody by surface plasmon resonance

With the development of bio-technological drugs, drug immunogenicity evaluation has become key factor of clarifying safety and efficacy of these drugs.  It has become the focus to establish a stable and reliable evaluation system.  Due to the advantages such as continuous real-time monitoring, surface plasmon resonance (SPR) technology has been widely used in bio-technological drugs immunogenicity assessments.  Our study applied this technology to detect anti-drug antibody (ADA) of a recombinant human anti-rabies monoclonal antibody NM57 in the sera of 48 volunteers admitted in phase I clinical trials.  This method could satisfy the basic requirements of detection of ADA.