In Biosimilar Analytical Development, Is A CQA Ever Not Critical?

The word "critical" implies a binary signal. The attribute is either existentially important or it's not.

In biosimilar development, there is a hierarchy of critical quality attributes (CQAs) to monitor during the comparative analytical assessment (CAA). During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, Biologics Consulting Group Principal Consultant Diana Colleluori said that attributes relating to immunogenicity and function pose a higher risk and must be closely monitored.