Scaling biologics from development to commercial manufacturing requires precision, consistency, and control across both drug substance and drug product processes. Variability during scale-up—particularly in bioreactor operations and lyophilization—can impact product quality, process efficiency, and supply reliability.
Predictive modeling and Process Analytical Technology (PAT) enable a more robust, data-driven approach to development and manufacturing. By combining mechanistic understanding with real-time analytics, these tools help teams anticipate risks, optimize processes, and improve operational performance.
In this webinar, our experts share how predictive models and PAT can be applied to strengthen biologics manufacturing from scale-up through commercial production. You will gain practical insights into how to improve process robustness, enable more reliable technology transfer, and enhance efficiency across the product lifecycle.
Key Learning Objectives
- Apply predictive modeling to improve bioreactor scale-up and reduce process risk
- Use mechanistic and empirical data to support robust scale-up and technology transfer
- Leverage PAT tools to enable real-time monitoring, control, and process optimization
- Define and apply design space strategies to improve lyophilization performance across scales
- Reduce variability and accelerate readiness through early technical alignment
