Drug product (DP) filling operations use complex filling technologies over a multidimensional parameter space. Design of high capability filling process for a diversity of products and fill configurations require thorough understanding of the filling technology via characterization of the associated design space. Utilizing a combination of pilot scale capabilities and modeling approaches provides an efficient mechanism to enable better process understanding, development of a robust process and minimize cost to operations by either reducing or eliminating the need for characterization studies at manufacturing sites.<br/>In this talk we will discuss some examples of this approach. This includes development of filling recipe and associated fill set parameters by the use of fluid flow models as well as pilot scale filling system. The model based approach allows us to explore a broad range of process parameters and product properties to minimize number of characterization experiments. The combination of modeling and pilot scale runs help identify the critical process conditions and design an optimum manufacturing process.

Design space characterization for filling process leveraging modeling and pilot scale capabilities

253rd National Meeting (2017)

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