Characterizing drug product continuous manufacturing residence time distributions of major/minor excipient step
1Process Design and Development, Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN 46285, United States.
Abstract:
The material residence time distribution in a continuous manufacturing process can be utilized to develop, design and justify the process control strategy. This paper successfully demonstrates using both major and minor formulation component step changes to determine the system response using either Near Infrared Spectroscopy or process parameters. These options provide development flexibility to determine the system's material residence time earlier in the development process and more cost effectively.
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