Comparability studies are important to ensure that process changes made during the process development and/or manufacturing will not have an adverse impact on the quality, safety and efficacy of biopharmaceuticals. According to the ICH Q5E guidelines, comparability studies should provide analytical confirmation that the drug substance or drug product has similar quality attributes, pre- and post-process changes, which could be necessary during drug development and/or after approval. To meet this goal, the product should be characterized at the process step most appropriate to detect a change in the quality attributes. The list of analytical tests for the comparability studies should be carefully selected to maximize the potential for detecting relevant differences in the quality attributes of the product that could result from the proposed process change.
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