Discovery biotherapeutics bioanalysis: challenges and possible solutions

“Discovery bioanalysis requires a balance between speed, cost savings and analytical experience to ensure that results can be interpreted accurately with appropriate caveats to allow projects to progress rapidly.” In a discovery setting, short project cycle times and limited resources can have the most impact on the bioanalytical strategy that is chosen to support a biotherapeutic program. Since several candidates are often screened early in a project lifecycle and these may have chimeric backbones and may not be in the final humanized form, it is often neither cost effective nor possible to generate optimal reagents, as it can take months...