Structural characterization methods for biosimilars: fit-for-purpose, qualified or validated

Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in- depth understanding of manufacturing processes. But how can we have confidence in the data obtained from characterization studies? The expectation from regulatory authorities when assessing methods for product characterization is that there will be some demonstration of their suitability to the task in hand. Here we look at those expectations and what steps can be taken to give confidence to the data produced by these analytical methods.