on 08-12-201504:03 AM - edited on 10-15-202110:58 AM by AnalyteGuru
In the last decade, the pharmaceutical market has made a major shift to biotech-based drugs, particularly monoclonal antibodies and engineered mAbs such as antibody–drug conjugates. By 2012, seven of the top 10 drugs were biopharmaceuticals, up from only one in 2004. The complexity of these protein therapeutics makes them much more challenging to analyze. As a result, analytical scientists working in the pharmaceutical industry and regulatory agencies must be armed with the latest techniques to enable full and robust characterization of biopharmaceuticals.