The QTPP and additional sources of information such as characterization studies, platform knowledge or literature are the basis for the list of quality attributes that are considered in the assessment.In addition, amino acid residues that may be critical for the efficacy, PK or safety of tafasitamab, crucial and potential interaction sites were identified by structural assessment of the molecule to support the assignment of CQAs.The impact scoring system was applied individually to each quality attribute to categorize the potential effect that a quality attribute has on efficacy/potency, PK, immunogenicity and safety.In a second step, the impact scores are multiplied with an uncertainty factor.