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

Mahsa Siavashpouri; Christina M. Bailey-Hytholt; Jean-Rene Authelin; Sanket Patke

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 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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vol. 76 no. 6 461-473

DOI

https://doi.org/10.5731/pdajpst.2021.012722

PubMed

35169038

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Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online December 2, 2022.

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previous version (February 15, 2022 - 08:07).
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Mahsa Siavashpouri^1,ⁱ,
Christina M. Bailey-Hytholt¹,
Jean-Rene Authelin² and
Sanket Patke^1,*

¹Biologics Drug Product Development, Sanofi, Framingham, MA; and
²Biologics Drug Product Development, Sanofi, Vitry, France

↵*Corresponding Author: One Mountain Rd., Framingham, MA 01701; Telephone: +1 (781) 265-9177; E-mail: Sanket.Patke{at}sanofi.com

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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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Keywords

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

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