Process Control’s Increasing Role in Biosimilar Approval
Tuesday, March 24, 2026 | 11:00 AM EDT | 1 Hour
Regulatory expectations for biosimilars are shifting from large clinical trials to deep process understanding. Approval now hinges on how effectively sponsors define and control critical process parameters (CPPs) and link them to the reference product’s critical quality attributes (CQAs). Robust process control has become central to demonstrating high similarity.
In this live Q&A, Jon O’Connell of Bioprocess Online leads a panel of industry and regulatory experts on applying Quality by Design (QbD) principles to biosimilar development. The discussion will cover translating reference product data into actionable process strategies, managing variability through risk-based controls, and aligning CMC programs with evolving global guidance.
Speakers include Sarfaraz K. Niazi, Ph.D.; Diana Colleluori, Ph.D., MBA; Vince Narbut; and Eva Temkin, former FDA policy leader.
Designed for CMC, process development, quality, and regulatory professionals, this session delivers practical insight on strengthening comparability strategies and positioning biosimilars for efficient regulatory approval.
