Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals

Jennifer Anderson; Christopher Thompson; Kang Cai; Joshua Orchard; Gisela Ferreira

doi:10.5731/pdajpst.2021.012674

Research ArticleTechnology/Application

Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals

Jennifer Anderson, Christopher Thompson, Kang Cai, Joshua Orchard and Gisela Ferreira

PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 27-37; DOI: https://doi.org/10.5731/pdajpst.2021.012674

Jennifer Anderson

1Purification Process Sciences, Biopharmaceutical Development, AstraZeneca, Gaithersburg, MD, USA; and

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Christopher Thompson

2Data Science and Modelling, Biopharmaceutical Development, AstraZeneca, Gaithersburg, MD, USA

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Kang Cai

1Purification Process Sciences, Biopharmaceutical Development, AstraZeneca, Gaithersburg, MD, USA; and

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Joshua Orchard

1Purification Process Sciences, Biopharmaceutical Development, AstraZeneca, Gaithersburg, MD, USA; and

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Gisela Ferreira

1Purification Process Sciences, Biopharmaceutical Development, AstraZeneca, Gaithersburg, MD, USA; and

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For correspondence: gisela.ferreira@astrazeneca.com

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vol. 77 no. 1 27-37

DOI

https://doi.org/10.5731/pdajpst.2021.012674

PubMed

35987517

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online February 6, 2023.

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previous version (August 19, 2022 - 21:18).
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Jennifer Anderson¹,
Christopher Thompson²,
Kang Cai¹,
Joshua Orchard^1,^# and
Gisela Ferreira^1,*

¹Purification Process Sciences, Biopharmaceutical Development, AstraZeneca, Gaithersburg, MD, USA; and
²Data Science and Modelling, Biopharmaceutical Development, AstraZeneca, Gaithersburg, MD, USA

↵* Corresponding Author: 1 MedImmune Way, Gaithersburg, MD 20878; Telephone: 301-398-2734; E-mail: gisela.ferreira{at}astrazeneca.com

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Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals

Jennifer Anderson, Christopher Thompson, Kang Cai, Joshua Orchard, Gisela Ferreira

PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 27-37; DOI: 10.5731/pdajpst.2021.012674

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Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals

Jennifer Anderson, Christopher Thompson, Kang Cai, Joshua Orchard, Gisela Ferreira

PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 27-37; DOI: 10.5731/pdajpst.2021.012674

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Keywords

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Virus safety
Virus clearance
Modular virus clearance
Virus safety factor
Sensitivity analysis

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