Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review

Jennifer Anderson; Chelsea Burgwin; Donna Hamilton

doi:10.5731/pdajpst.2024-003024.1

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Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review

Jennifer Anderson, Chelsea Burgwin and Donna Hamilton

PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003024; DOI: https://doi.org/10.5731/pdajpst.2024-003024.1

Jennifer Anderson

AstraZeneca USA

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Chelsea Burgwin

GSK USA

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Donna Hamilton

BioPhorum

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For correspondence: donna.hamilton@biophorum.com

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pdajpst.2024-003024

DOI

https://doi.org/10.5731/pdajpst.2024-003024.1

PubMed

40300811

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received October 23, 2024
Accepted March 29, 2025
Published online April 29, 2025.

Author Information

Jennifer Anderson,
Chelsea Burgwin and
Donna Hamilton (donna.hamilton{at}biophorum.com)

AstraZeneca USA
GSK USA
BioPhorum

Donna Hamilton, The Gridiron Building 1 Pancras Square, N1C 4AG, London, United Kingdom +447980416159 Donna.hamilton{at}biophorum.com Donna.wilkinson{at}talk21.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 2

March/April 2025

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Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review

Jennifer Anderson, Chelsea Burgwin, Donna Hamilton

PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003024; DOI: 10.5731/pdajpst.2024-003024.1

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Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review

Jennifer Anderson, Chelsea Burgwin, Donna Hamilton

PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003024; DOI: 10.5731/pdajpst.2024-003024.1

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Keywords

Viral clearance
packed bed chromatography
resin re-use
Protein A
anion exchange
ICH Q5A(R2)

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