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

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   09 Jun 2023 | Contributor(s):: Shi, Zhenqi, Manley, Leo

   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...