A Risk-Based Approach for Managing Affinity Resin Contaminations

Beth Fulton; Angelica Welch

doi:10.5731/pdajpst.2022.012814

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A Risk-Based Approach for Managing Affinity Resin Contaminations

Beth Fulton and Angelica Welch

PDA Journal of Pharmaceutical Science and Technology September 2023, 77 (5) 420-435; DOI: https://doi.org/10.5731/pdajpst.2022.012814

Beth Fulton

ValSource Inc.

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For correspondence: bfulton@valsource.com

Angelica Welch

ValSource Inc.

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vol. 77 no. 5 420-435

DOI

https://doi.org/10.5731/pdajpst.2022.012814

PubMed

37451834

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 6, 2023.

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previous version (July 14, 2023 - 05:53).
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Beth Fulton* and
Angelica Welch

ValSource Inc.

↵*Corresponding Author: ValSource Inc., 918A Horseshoe Pike, Downington PA 19335; Telephone: 603-661-1294, E-mail: bfulton{at}valsource.com

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A Risk-Based Approach for Managing Affinity Resin Contaminations

Beth Fulton, Angelica Welch

PDA Journal of Pharmaceutical Science and Technology Sep 2023, 77 (5) 420-435; DOI: 10.5731/pdajpst.2022.012814

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A Risk-Based Approach for Managing Affinity Resin Contaminations

Beth Fulton, Angelica Welch

PDA Journal of Pharmaceutical Science and Technology Sep 2023, 77 (5) 420-435; DOI: 10.5731/pdajpst.2022.012814

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Keywords

Affinity resin
Protein A
Risk-based impact assessment
RBIA
Contamination
bioburden
Biofilm
Chromatography

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