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Case ReportCase Studies

A Quality by Design Approach to Microbial Retention Validation

Annie Leahy, Jennifer Juneau, Kathleen Souza, Corinne Miller, Nhung Nguyen, Herb Lutz and Parag Kolhe
PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 18-26; DOI: https://doi.org/10.5731/pdajpst.2022.012739
Annie Leahy
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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  • For correspondence: annie.leahy@milliporesigma.com
Jennifer Juneau
2Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA
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Kathleen Souza
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Corinne Miller
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Nhung Nguyen
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Herb Lutz
1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and
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Parag Kolhe
2Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA
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PDA Journal of Pharmaceutical Science and Technology: 77 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 1
January/February 2023
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A Quality by Design Approach to Microbial Retention Validation
Annie Leahy, Jennifer Juneau, Kathleen Souza, Corinne Miller, Nhung Nguyen, Herb Lutz, Parag Kolhe
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 18-26; DOI: 10.5731/pdajpst.2022.012739

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A Quality by Design Approach to Microbial Retention Validation
Annie Leahy, Jennifer Juneau, Kathleen Souza, Corinne Miller, Nhung Nguyen, Herb Lutz, Parag Kolhe
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 18-26; DOI: 10.5731/pdajpst.2022.012739
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