(355f) Spray Drying Process Development and Technology Transfer By Modeling and Simulation

Spray drying is a scale dependent phenomenon and the CMA to CPP to CQA correlations varies between the scales and types and designs of the spray dryer equipment. The particle engineering and lab scale manufacturing for clinical trials are not easily scaled to the manufacturing scales equipment, as well as technology transfer between different CMOs. However, when a product is being developed and registered for regulatory approval at the lab scale, the defined particle properties, CQAs, and impact on the downstream processes should be kept relatively constant for the large scale manufacturing. Therefore, the technology transfer from CRO to CMO requires performing new sets of DoEs to define the new CPPs. In this case, significant amounts of materials and time required to be spent for experimental approach.

The transport phenomena, atomization, particle formation, drying, and equipment characterization can be simulation by high fidelity simulations and rigorous mathematical models. These models should be comprehensive to capture all physics, thermodynamics, material properties, and equipment performance. The benefit of performing such simulation is to develop the design space and capture all system nonlinearities, and define the optimum conditions in a rapid and efficient way.

This presentation will discuss the workflow and technical details of such approach with industrial case studies. Two case studies for scale-up from lab to manufacturing scale, and technology transfer for two different sizes and designs of spray dryer will be demonstrated. The validation results will be discussed to demonstrate the comparison between the simulations results and experimental cases. Challenges, benefits, and technical aspects of the simulation applications will be discussed.