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LyoPRONTO: Deterministic and Probabilistic Modeling – Tutorial and Case Study

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Principles and Practices of Lyophilization in Product Development and Manufacturing

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 59))

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Abstract

The current work extends the application of the Lyophilization and Process Optimization Tool (LyoPRONTO) from the deterministic (Shivkumar et al. AAPS PharmSciTech 2019;20(8):1–17) to the probabilistic approach taking into account the process parameters variations and uncertainties in the primary drying cycle. The step-by-step tutorial of using the online tool which includes the examples of freezing and primary drying calculator usage, design space generation, and primary drying optimization to create more efficient cycles is presented. In addition, the upgraded optimization procedure is shown which provides more flexibility towards practical applications. The tutorial includes the detailed test cases with thorough instructions. Also, the additional experimental validation is provided for the probabilistic approach.

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Authors and Affiliations

  1. Purdue University, West Lafayette, IN, USA

    Petr Kazarin & Alina Alexeenko

Authors
  1. Petr Kazarin
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  2. Alina Alexeenko
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Corresponding author

Correspondence to Alina Alexeenko .

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Editors and Affiliations

  1. Nimble BioSolutions, Gurnee, IL, USA

    Feroz Jameel

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© 2023 America Association of Pharmaceutical Scientists

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Kazarin, P., Alexeenko, A. (2023). LyoPRONTO: Deterministic and Probabilistic Modeling – Tutorial and Case Study. In: Jameel, F. (eds) Principles and Practices of Lyophilization in Product Development and Manufacturing . AAPS Advances in the Pharmaceutical Sciences Series, vol 59. Springer, Cham. https://doi.org/10.1007/978-3-031-12634-5_15

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