Friday, September 21, 2012
Automated miniaturization of a homogeneous assay for Immunogenicity testing of biological drug products
In just about a week from now BioTek will be presenting several posters and presentations at MipTec in Basel, Switzerland. Several of those will discuss current assay methods used in the field of biologics for research and development. As a preview to the content that will be presented in one of the posters, here we give a peak at some preliminary data acquired while adapting an AlphaLISA anti-drug antibody (ADA) immunogenicity assay from a 96- to a 384-well microplate format suitable for automated methods.
ADA assays can provide information to help better understand a common challenge faced when evaluating biological drug products; a common immune response in patients is the development of anti-drug antibodies towards the therapeutic drug of interest. While the response is understood to be nearly universal, the extents to which ADAs impact safety and efficacy during treatment vary widely and are difficult to determine due to ADAs being nearly indistinguishable from the therapeutic drug of interest. While several technology platforms exist to measure immunogenicity, a homogeneous bridging assay format provides a simple workflow with high sensitivity and higher-throughput capabilities than other such methods such as solution ELISA based assays. The AlphaLISA assay platform relies on bridging labeled drug antibody by a bispecific ADA (see below).