Recifercept is a medium-sized biologic with a complex glycan profile. During analytical development, multiple challenges were encountered related to the large amount of sialylation present. Moreover, during late-stage process development, changes occurred in both upstream and downstream manufacturing, resulting in drug substances with different product quality attributes. This presentation focuses on the design, execution, and interpretation of the analytical comparability study that was used to support the late-stage process.
Learning Objectives:
Attendees will learn how biotherapeutics can be complex even though not large in size.
Attendees will understand the analytical assays required to monitor manufacturing process changes.
Attendees will view an analytical comparability study and learn how to communicate results.
