Protein Biopharmaceuticals–Challenges in Characterisation
Monoclonal antibody (mAb) biopharmaceuticals form the largest part of a growing biotherapeutics drug market and produced a requirement to develop new analytical characterisation methods. These large biomolecules are very different from the world of small molecule drugs and require different types of characterisation with very different methodology. Small molecules produce a limited number of impurities compared to a mAb which theoretically can have almost 10,000 variant molecules due to the size and complexity.
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