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Int J Pharm. 2018 Nov 15;551(1-2):60-66. doi: 10.1016/j.ijpharm.2018.08.059. Epub 2018 Aug 31.

Characterizing drug product continuous manufacturing residence time distributions of major/minor excipient step changes using near infrared spectroscopy and process parameters.

Author information

1
Process Design and Development, Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN 46285, United States. Electronic address: manley@lilly.com.
2
Process 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.

KEYWORDS:

Continuous manufacturing; Drug product; Residence time distribution; Soft sensors

PMID:
30176367
DOI:
10.1016/j.ijpharm.2018.08.059
[Indexed for MEDLINE]

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