Case Study

Evaluating Milling Conditions For Scaling Up A Nanosuspension Drug Product

Source: Altasciences
GettyImages-1306664598 lab research

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.

access the Case Study!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Outsourced Pharma? Subscribe today.

Subscribe to Outsourced Pharma X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Outsourced Pharma