Building A Comprehensive Control Strategy For Biosimilar Analytics

Like many other biologic drugs, building a comprehensive controls strategy for biosimilars starts with defining critical quality attributes (CQAs), said Vince Narbut, a principal consultant at Biologics Consulting Group, during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.

From there, biosimilar sponsors must map out the critical process parameters (CPPs) used to control upstream and downstream manufacturing, he said. It starts to get tricky when you introduce the originator product's specification range. Narbut said most of the iterative adjustments happen on the upstream side where you can tweak glycan profiles and charge variants.