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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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Abstract

Regulatory and manufacturing requirements exist for performance of product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to sterilizing filtration supports a paradigm that would obviate the need for product-specific testing for early-stage products that do not have the quantity of material required to perform such testing easily and efficiently. Process and product parameters were varied to determine their effect on microbial retention to define a design space. To minimize the burden of filter validation retention studies for early-stage (Phase 1) manufacturing, it is recommended that manufacturers perform a risk assessment to confirm their product and process conditions are within the established design space. For later stage product development prior to marketing authorization, product-specific filter validation testing is expected.

  • Final fill
  • Quality by Design
  • Sterilizing-grade filters
  • Validation
  • © PDA, Inc. 2023
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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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