Whilst many parameters connected to developing and manufacturing process that might predispose monoclonal antibodies to cause immune response are well known and appropriate steps are taken to monitor and control these unwanted effects, complications linked with administration of monoclonal antibodies to genetically diverse human population are less well described.
The use of monoclonal antibodies is subject to several factors related to their production and manufacturing processes that can trigger an immune response. Nevertheless, the challenges associated with administering these antibodies to individuals with varying genetic backgrounds have not been extensively studied.