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

Mahsa Siavashpouri; Christina Bailey-Hytholt; Jene-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 Bailey-Hytholt, Jene-Rene Authelin and Sanket Patke

PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2021.012722; DOI: https://doi.org/10.5731/pdajpst.2021.012722

Mahsa Siavashpouri

1 Amgen Inc.;

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For correspondence: m.siavashpouri@gmail.com

Christina Bailey-Hytholt

2 Sanofi

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For correspondence: christina.bailey@sanofi.com

Jene-Rene Authelin

2 Sanofi

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For correspondence: jean-rene.authelin@sanofi.com

Sanket Patke

2 Sanofi

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For correspondence: sanket.patke@sanofi.com

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pdajpst.2021.012722

DOI

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

PubMed

35169038

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received December 4, 2021
Accepted February 14, 2022
Published online February 15, 2022.

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Author Information

Mahsa Siavashpouri1 (m.siavashpouri{at}gmail.com),
Christina Bailey-Hytholt2 (christina.bailey{at}sanofi.com),
Jene-Rene Authelin2 (jean-rene.authelin{at}sanofi.com) and
Sanket Patke2,3 (sanket.patke{at}sanofi.com)

¹ Amgen Inc.;
² Sanofi

↵* Corresponding author; email: sanket.patke{at}sanofi.com

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

Mahsa Siavashpouri, Christina Bailey-Hytholt, Jene-Rene Authelin, Sanket Patke

PDA Journal of Pharmaceutical Science and Technology Feb 2022, pdajpst.2021.012722; 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 Bailey-Hytholt, Jene-Rene Authelin, Sanket Patke

PDA Journal of Pharmaceutical Science and Technology Feb 2022, pdajpst.2021.012722; DOI: 10.5731/pdajpst.2021.012722

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Keywords

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

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