Bioanalytical Support in the Development of Biologics
The Need for Sensitivity Combined with Broad Assay Range – Case Studies
Dr. Christian Pieper
Biologics are highly complex molecules which have their origin in biological processes and are used to obtain high efficient drugs. The most common class of biologics are monoclonal and bi-specific antibodies which can be difficult in finding of optimal dosing. As a consequence of safety considerations, initial dosing in clinical trials is often very low and may require ultra sensitive ligand-binding assay (LBA) support. In addition, the therapeutic dose of antibody drugs can vary significantly, depending on binding targets, potency and physiological effects. For dose range finding, not only sensitivity but equally important broad assay range is a key feature. Most ultra sensitive LBA technologies however, lack continuous dynamic range. Exponential signal amplification on Immuno-PCR (IPCR) based Imperacer® platform combines broad assay range of better than 4 logs with excellent sensitivities for optimal PK sample testing support.