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 May 2025, 79 (3) 320-336; DOI: https://doi.org/10.5731/pdajpst.2024-003024.1

Jennifer Anderson

1AstraZeneca, USA;

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Chelsea Burgwin

2GSK, USA; and

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Donna Hamilton

3BioPhorum

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For correspondence: donna.hamilton@biophorum.com

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vol. 79 no. 3 320-336

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

Published online June 2, 2025.

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previous version (April 29, 2025 - 09:48).
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Jennifer Anderson¹,
Chelsea Burgwin² and
Donna Hamilton^3,*

¹AstraZeneca, USA;
²GSK, USA; and
³BioPhorum

↵* Corresponding Author: The Gridiron Building, 1 Pancras Square, N1C 4AG, London, United Kingdom; Telephone +447980416159; E-mail: donna.hamilton{at}biophorum.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 3

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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 May 2025, 79 (3) 320-336; 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 May 2025, 79 (3) 320-336; DOI: 10.5731/pdajpst.2024-003024.1

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Keywords

Viral clearance
Packed bed chromatography
Resin reuse
Protein A
Anion exchange
ICH Q5A(R2)

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