Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging (Figure 1). Matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor throughout the production process. Figure 1: ()   Some residual impurities are introduced in the upstream steps as…