Small molecule drugs continue to dominate the drug pipeline in volume terms, but biologic therapeutics are an alternative, and increasingly important, therapeutic class. Within biologics, a growing number of novel modalities are now emerging, with next-generation biologics incorporating the already heterogeneous features that are present in monoclonal antibodies (mAbs) and other proteins, and adding new layers of molecular complexity.
The added intricacy of these molecular moieties and characteristics means the number of critical quality attributes (CQAs) that need to be monitored is increasing. Newer analytical methods are therefore required to ensure the purity and characteristics of the drugs, resulting in safe and efficacious medicines. Here, mass spectrometry…