Wet milling offers efficient production of a consistent, high-quality particle size distribution (PSD) in active pharmaceutical ingredients (APIs). However, scaling from the laboratory to plant is a challenge. Scale-up methods that depend on a single parameter can result in inaccurate predictions and longer processing time and produce off-target PSD at the plant scale.
Learn more about model aided scale-up for wet milling in our article in Organic Process Research & Development (OPR&D). Veranova’s Principal Process Engineer, Dr. Ankur Kapil, Senior Scientist, Lorrayne Clague, and Director of Process Engineering, Michael Hamlin, outlined a framework for the reliable, adaptable, and efficient scale-up of wet milling across different APIs and equipment to improve reliability and efficiency in pharmaceutical production.
This study introduces a model-aided workflow for scaling wet milling processes from the laboratory to the plant using multiparameter population balance modeling (PBM) in gFormulate. The PBM model was developed at the laboratory scale (80–125 g), adjusted by a single parameter at the kiloscale (1.5 kg), and applied to the plant scale (50 kg) without any additional changes. The model achieved right-first-time results for the predicted conditions (e.g., 26 h processing time): 55 ± 2 μm, 95% yield at the plant scale. This framework provides a reliable, adaptable solution for efficient scale-up of wet milling across different APIs and equipment, improving reliability and efficiency in pharmaceutical production.
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