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Research ArticleResearch

Quantification and Stability Impact Assessment of Drop Stresses in Biologic Drug Products

Mahsa Siavashpouri, Christina M. Bailey-Hytholt, Jean-Rene Authelin and Sanket Patke
PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 461-473; DOI: https://doi.org/10.5731/pdajpst.2021.012722
Mahsa Siavashpouri
1Biologics Drug Product Development, Sanofi, Framingham, MA; and
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Christina M. Bailey-Hytholt
1Biologics Drug Product Development, Sanofi, Framingham, MA; and
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Jean-Rene Authelin
2Biologics Drug Product Development, Sanofi, Vitry, France
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Sanket Patke
1Biologics Drug Product Development, Sanofi, Framingham, MA; and
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  • For correspondence: Sanket.Patke@sanofi.com
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PDA Journal of Pharmaceutical Science and Technology: 76 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 6
November/December 2022
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Quantification and Stability Impact Assessment of Drop Stresses in Biologic Drug Products
Mahsa Siavashpouri, Christina M. Bailey-Hytholt, Jean-Rene Authelin, Sanket Patke
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 461-473; DOI: 10.5731/pdajpst.2021.012722

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Quantification and Stability Impact Assessment of Drop Stresses in Biologic Drug Products
Mahsa Siavashpouri, Christina M. Bailey-Hytholt, Jean-Rene Authelin, Sanket Patke
PDA Journal of Pharmaceutical Science and Technology Nov 2022, 76 (6) 461-473; DOI: 10.5731/pdajpst.2021.012722
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  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Size-Exclusion Chromatography
    • Liquid Chromatography-Mass Spectrometry Peptide Mapping
    • Subvisible Particle Analysis by Micro-Flow Imaging (MFI)
    • Turbidity
    • Results and Discussion
    • Conclusion
    • Conflict of Interest Declaration
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Keywords

  • Transportation stress
  • Drop stress
  • Cavitation
  • Friability
  • Interfacial stress
  • Scale-down models

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