Value of Attribute Risk Ranking in Process Development Recognized by ICH Q11 EWG

The current working draft of ICH Q11 promotes the use of risk ranking of quality attributes as a valuable tool in applying quality-by-design (QbD) principles to biotech drug substance development and manufacturing.

The focus by the ICH Expert Working Group (EWG) on the risk-ranking approach in Q11 reflects its growing acceptance as a means of addressing the criticality of quality attributes and communicating to regulators the rationale for how they will be controlled.

CDER Division of Monoclonal Antibodies (DMA) Deputy Director Patrick Swann, who represents FDA on the Q11 EWG, explained the attraction to the risk-ranking approach at the mid-January CASSS/FDA Well Characterized Biotechnology Pharmaceutical (WCBP) conference in Washington, D.C.

The final session of the WCBP addressed the EWG progress on Q11.  Also at the session was Q11 rapporteur Brian Withers (Abbott UK), who gave an overview of the guideline’s progress (IPQ “In the News” Jan. 24) and discussed how the group is approaching biotech process validation (IPQ “In the News” Jan. 27).

Swann focused on the handling of manufacturing process development for biotech products in Q11.  Along with the risk ranking and critical quality attribute (CQA) issues, he covered the difference in requirements for traditional versus enhanced approaches in development and manufacturing, consistency of Q11 with Q8, design space and the use of platform technology.

[More on Swann’s discussion of how the EWG is handling process development for biotech products is provided for subscribers here.  Non-subscribers can purchase the full story for $95 by contacting Karen Bertani (  For subscription information click here.]