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This talk is going to discuss factors to consider when assessing comparability between a Follow-on Protein Product and its reference protein product.Specifically,the following factors will be discussed:●The role of protein expression system and manufacturing process in determining product quality attributes ●What analytical techniques should be selected for product characterization and comparability studies? ● The role of biological activity assays ● How to handle impurities? The role of comparators and reference standards for assessing similarity ● Pharmaceutical ingredients and formulation ●Stability.