Analysis of virus clearance for biotechnology manufacturing processes from early to late phase development

Opeyemi O. Ajayi; Jackie L. Cullinan; Innara Basria; Madaisabel Fuentes-Arias; Ashley Osuna-Najarro; Sarah Johnson; Talia Faison; Scott Lute

doi:10.5731/pdajpst.2025-000001.1

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Analysis of virus clearance for biotechnology manufacturing processes from early to late phase development

Opeyemi O. Ajayi, Jackie L. Cullinan, Innara Basria, Madaisabel Fuentes-Arias, Ashley Osuna-Najarro, Sarah Johnson, Talia Faison and Scott Lute

PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2025-000001; DOI: https://doi.org/10.5731/pdajpst.2025-000001.1

Opeyemi O. Ajayi

1Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment III (OPQA III), Division of Product Quality Assessment XIV (DPQA XIV)

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For correspondence: opeyemi.ajayi@fda.hhs.gov

Jackie L. Cullinan

2CDER, OPQ, Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research VI (DPQR VI)

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Innara Basria

2CDER, OPQ, Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research VI (DPQR VI)

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Madaisabel Fuentes-Arias

2CDER, OPQ, Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research VI (DPQR VI)

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Ashley Osuna-Najarro

2CDER, OPQ, Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research VI (DPQR VI)

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Sarah Johnson

1Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment III (OPQA III), Division of Product Quality Assessment XIV (DPQA XIV)

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Talia Faison

3CDER, OPQ, Office of Pharmaceutical Manufacturing Assessment (OPMA), Division of Pharmaceutical Manufacturing Assessment VI (DPMA VI)

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Scott Lute

2CDER, OPQ, Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research VI (DPQR VI)

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For correspondence: Scott.Lute@fda.hhs.gov

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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Analysis of virus clearance for biotechnology manufacturing processes from early to late phase development

Opeyemi O. Ajayi, Jackie L. Cullinan, Innara Basria, Madaisabel Fuentes-Arias, Ashley Osuna-Najarro, Sarah Johnson, Talia Faison, Scott Lute

PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2025-000001; DOI: 10.5731/pdajpst.2025-000001.1

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Analysis of virus clearance for biotechnology manufacturing processes from early to late phase development

Opeyemi O. Ajayi, Jackie L. Cullinan, Innara Basria, Madaisabel Fuentes-Arias, Ashley Osuna-Najarro, Sarah Johnson, Talia Faison, Scott Lute

PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2025-000001; DOI: 10.5731/pdajpst.2025-000001.1

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Keywords

Viral Safety
Virus Clearance
Low pH inactivation
Virus-Retentive Filtration
Chromatography Viral Clearance
Pharmaceutical Viral Clearance
Retrovirus-Like Particle Clearance
Safety Factor

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Parenteral Drug Association, Inc.