Critical Quality Attributes Workshop Session One Critical Quality Attributes Control Strategy for Glycosylation Using a QbD Approach: Monoclonal Antibody with Effector Function from the A-Mab Case Study Victor Vinci, Eli Lilly and Company 2.   CQA Assessment for Glycosylation and Oxidation of a Monoclonal Antibody: An FDA Pilot Program Case Study Andy Weiskopf, Biogen Idec 3.   CQA Assessment of Fc glycosylation for Mabs targeting soluble antigens Bhavin Parekh, Eli Lilly and Company

Questions 1.       In assessing which attributes are critical and which are not, to what extent is it appropriate to apply prior knowledge from similar class molecules to a new product?    When is it appropriate to leverage company-specific and literature information?  How much additional molecule-specific information would be required to support the assessment? 2.     In setting and justifying acceptable ranges for CQAs, what information is required?   a)     When is pre-clinical data sufficient and when is clinical data required?  To what extent is prior knowledge with similar class molecules applicable to setting ranges for CQAs?  How does stability play into establishing acceptable CQA ranges?  b)    How do we reconcile the value of establishing broader clinical exposure to product variants with the goals of product development, which continually drives towards comparability, consistency, and higher purity?  How does a company broaden CQA ranges based on safety and efficacy considerations? 3.     What aspects should be considered when assessing interactions between quality attributes?  Can the interaction of non-critical attributes render them critical?  What information would be required to establish the absence of interactions?