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Activity Number: 355
Type: Contributed
Date/Time: Tuesday, August 2, 2016 : 10:30 AM to 12:20 PM
Sponsor: Section on Physical and Engineering Sciences
Abstract #318792 View Presentation
Title: Innovative and Efficient Definitive Screening Designs with an Asymptotic Method for Defining the End of Primary Drying Time to Optimize the Freeze-Drying Process
Author(s): Oksoun Yee* and Johnathan Goldman and Haresh More
Companies: Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb
Keywords: definitive screening design ; freeze-drying ; four-parameter logistic ; optimization
Abstract:

Traditional optimization of the freeze-drying process has been explored with a limited number of lyophilization process parameters. We used innovative definitive screening designs to study the effects of eight formulation, process, filling and instrument factors in just 20 runs, with the ability to estimate a full quadratic model in any three factors. The analysis of these data involved comparing a conventional intersection method for defining the end of primary drying time (intersection of product and shelf temperature) with an asymptotic method via fitting a four-parameter logistic curve to the product temperature profile. A final mixed model characterizing the effects of the eight factors and location effects within a lyophilization run is described which provides a thorough understanding and prediction of the end of primary drying time.


Authors who are presenting talks have a * after their name.

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