Session: 06-08-04: Computational Modeling in Biomedical Applications

Paper Number: 142769

142769 - Advancing Technology Transfer in Secondary Biopharmaceutical Manufacturing With Single-Use Systems Through Modeling 

Liquid mixing plays a vital role in pharmaceutical manufacturing, particularly in formulations such as injectables and oral solutions. However, challenges such as inadequate mixing, non-homogeneity, and shear sensitivity can significantly impact product quality, potentially leading to batch failure. In Secondary Biopharmaceutical Manufacturing, the adoption of Single-Use Systems (SUS) has presented several advantages, including flexibility, reduced contamination risk, cost-efficiency, and overall improvements in efficiency and safety. Despite these benefits, achieving consistent mixing across different geometries remains complex due to the diverse shapes and sizes of SUS mixing vessels and proprietary impellers. Additionally, transferring operations to different sites or facing shortages of single-use bags further complicates the situation, necessitating backup plans and potential transitions to different mixing geometries while ensuring maintained product quality.

Conducting experiments with various mixing equipment may not be feasible or cost-effective due to resource constraints. Therefore, simulations offer a promising alternative for assessing mixing equipment and optimizing parameters such as power per volume (P/V) and shear to ensure product quality. This facilitates the technology transfer process and minimizes product quality degradation. Understanding the significance of engineering parameters over equipment specifications is crucial, especially in scaling out mixing operations. In this study, different SUS mixing equipment under various operating conditions and product properties have been examined and compared for scale out purposes. By employing computational fluid dynamics (CFD), we ensure that different SUS mixing equipment operates under similar engineering parameters such as P/V, thereby indicating comparable end-product quality and facilitating the technology transfer and optimization of pharmaceutical manufacturing processes.

Presenting Author: Elaheh Ardalani GSK

Presenting Author Biography: Elaheh Ardalani is an Investigator in Modeling & Simulation at GlaxoSmithKline (GSK) since January 2023. She earned her PhD in Mechanical Engineering, specializing in DEM, heat transfer, scale-up, and compaction. Her Master's focused on FEM and stress/strain analysis. At GSK, she works on process modeling, scale-out, and optimization for drug substance and product development, covering both early and late phases.

Authors:

Elaheh Ardalani GSK
Mark Palmer GSK
Gabriele Bano GSK
Sayantan Chattoraj GSK