Standards' Role In Biosimilarity Assessment

Standards are useful tools for specific purposes, but they represent a one-point target. They do not capture the full range of variability found in reference products on the market.

During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, Alvotech Managing Director and Head of R&D Strategy Cecilia Michel said they provide an important basis for potency assays; however, they lack the dexterity for comparison of a broad range of attributes.