Advanced analytical strategies for the characterisation of biotherapeutics

Monoclonal antibodies (mAbs) are the most dominant selling class of biotherapeutics in the global market. These complex biomolecules are produced through mammalian cell culture and are prone to structural heterogeniety. This heterogeniety can have an adverse effect on the overall stability and efficacy of the drug product and must be closely monitored through product characterisation. Characterisation of mAbs can be carried out on the intact, subunit and peptide level. The drawback with traditional characterisation techniques include high sample requirement, high level of expertise needed to produce reporducible data and the methods involved are usually time consuming. The objective of this work was develop characterisation strategies at all three levels using novel instrumentation to overcome these drawbacks and improve our understanding of product characteristics at all stages of the mAb production cycle.