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Particle Property Characterization and Data Curation for Effective Powder Property Modeling in the Pharmaceutical Industry

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Abstract

Computational modeling, machine learning, and statistical data analysis are increasingly utilized to mitigate chemistry, manufacturing, and control failures related to particle properties in solid dosage form manufacture. Advances in particle characterization techniques and computational approaches provide unprecedented opportunities to explore relationships between particle morphology and drug product manufacturability. Achieving this, however, has numerous challenges such as producing and appropriately curating robust particle size and shape data. Addressing these challenges requires a harmonized strategy from material sampling practices, characterization technique selection, and data curation to provide data sets which are informative on material properties. Herein, common sources of error in particle characterization and data compression are reviewed, and a proposal for providing robust particle morphology (size and shape) data to support modeling efforts, approaches for data curation, and the outlook for modeling particle properties are discussed.

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Acknowledgements

The authors would like to thank Srini Sridharan and Tracy Gaebele for their guidance and support during the authorship of this manuscript.

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Authors and Affiliations

  1. Drug Product Development, Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, New Jersey, 08901, USA

    Robert C. Wadams, Jacob Albrecht, Yue Schuman & Lauren Taylor

  2. Drug Product Development, Bristol Myers Squibb, Summit West, New Jersey, USA

    Ilgaz Akseli & Stephen Thomas

  3. Sage Bionetworks, Princeton, New Jersey, USA

    Jacob Albrecht

  4. Drug Product Development, Bristol Myers Squibb, Reeds Lane, Moreton, UK

    Ana P. Ferreira, John F. Gamble, Michael Leane & Mike Tobyn

Authors
  1. Robert C. Wadams
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  2. Ilgaz Akseli
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  3. Jacob Albrecht
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  4. Ana P. Ferreira
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  5. John F. Gamble
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  6. Michael Leane
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  7. Stephen Thomas
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  8. Yue Schuman
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  9. Lauren Taylor
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  10. Mike Tobyn
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by John Gamble, Yue Schuman, Lauren Taylor, and Robert C. Wadams. The first draft of the manuscript was written by Robert C. Wadams and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Robert C. Wadams.

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Wadams, R.C., Akseli, I., Albrecht, J. et al. Particle Property Characterization and Data Curation for Effective Powder Property Modeling in the Pharmaceutical Industry. AAPS PharmSciTech 23, 286 (2022). https://doi.org/10.1208/s12249-022-02434-2

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