Driving Robust Tech Transfer In Biologics: Computational Fluid Dynamics (CFD) Simulation

The successful transfer of a biologics manufacturing process from a smaller scale to commercial production is a pivotal, yet often complex, stage. Relying solely on empirical experimentation during scale-up introduces substantial risks and can lead to significant developmental delays.

Computational Fluid Dynamics (CFD) simulation offers a powerful, model-based approach to address these challenges. It provides a virtual environment to predict and optimize fluid flow, mixing, and mass transfer behavior within critical equipment like bioreactors and purification systems. Understanding and mitigating the variations introduced by scaling is paramount for maintaining product quality and consistency. By leveraging CFD, teams can rapidly assess different geometries and operating parameters, ensuring process robustness before committing to costly physical runs.

• Expand QbD Knowledge: Understand how CFD extends process knowledge beyond traditional scale-up and tech transfer methods.
• Support Process Assessment: Discover how CFD aids facility fit assessments, enables "what-if" scenario analysis, and supports impact/risk evaluations during process scale-up and transfer.
• Increase Efficiency and Robustness: Learn how virtual experimentation reduces the need for expensive physical trials, strengthens process robustness, and serves as a crucial differentiator for CDMOs in a competitive market.