Evaluating Milling Conditions For Scaling Up A Nanosuspension Drug Product

Altasciences was engaged by a client seeking expertise in scaling up the manufacturing of their nanosuspension drug product for Phase 3 clinical trials. The objective was to optimize current manufacturing conditions to achieve a 200 L theoretical yield. The study focused on evaluating milling conditions for the consistent and reliable production of the nanosuspension product. The drug, classified as a small molecule (BSC Class II), was intended for oral administration. The chosen equipment for the study was the NETZSCH DeltaVita® 10000 milling system.

The primary purpose of the investigation was to enhance and fine-tune the milling conditions crucial for the manufacturing process of the drug nanosuspension. The ultimate goal, however, was to attain the target particle size at the desired 200 L theoretical yield, a prerequisite for supporting Phase 3 clinical trials. The study involved conducting a series of 10 pilot batches, marking a crucial step in the progression toward successful Phase 3 clinical studies. The findings from this research would contribute valuable insights into the efficient production of the nanosuspension drug product at an escalated scale.