Characterizing Biotherapeutics

"Although monoclonal antibodies comprise the largest share of approved therapeutic molecules, many new non-antibody modalities are being evaluated in the clinic. These new biologics are more complex, which comes as a result of a greater understanding of underlying disease biology as well as advanced engineering approaches. All recombinant proteins made for both research purposes and as therapeutic moieties undergo in depth analytical characterization using a variety of tools including mass spectrometry. As molecules increase in their complexity, the analytical field has had to keep up with improvements in the high-throughput, complexity, and sensitivity of characterization techniques"-- Provided by publisher.