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Research ArticleResearch

Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys

Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao and Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 4-27; DOI: https://doi.org/10.5731/pdajpst.2024.012964
Steven A. Zdravkovic
1Baxter;
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Qiang Fu
2Hikma;
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Aaron Flick
3American Regent;
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Bhargava Jana
1Baxter;
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Elizabeth Looney
4Pfizer;
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Samuel Kikandi
5Sanofi; and
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Tim Verdonck
1Baxter;
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Lee Nagao
6Faegre, Drinker, Biddle and Reath
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Mary Kate Bielinski
6Faegre, Drinker, Biddle and Reath
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  • For correspondence: marykate.bielinski@faegredrinker.com
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Abstract

Substances that can be extracted (extractables) from the components of a medical device or a pharmaceutical product’s manufacturing, packaging, and/or delivery system(s) are characterized as part of an extractable screening study to ensure the safety of the associated therapy. While the requirements of such studies have been established on a strategic level, the tactical approaches for their execution are less controlled, and as such, have been established on a laboratory-by-laboratory basis. Based on anecdotal accounts, differences in these tactical variables have resulted in inconsistent data obtained between laboratories when all other factors are equal. To better understand this potential issue, the Lab Practices Working Group within the Extractable & Leachable Safety Information Exchange (ELSIE) has conducted two surveys of the practices used by several pharmaceutical sponsors and contract research organizations for their execution of extractable screening studies. The results obtained from these surveys uncovered a lack of alignment in some experimental variables for the execution of these studies including selection and use of surrogate standard(s), establishment of system suitability, qualification of screening methods, and use of uncertainty factors. Accordingly, it was concluded that the potential exists for at least some differences in the data obtained from extractable screening studies between laboratories due to the inconsistencies in their execution uncovered in these surveys.

  • Extractable
  • Screening study
  • Uncertainty factor
  • Alignment
  • Inconsistent data
  • © PDA, Inc. 2025
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 4-27; DOI: 10.5731/pdajpst.2024.012964
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Keywords

  • Extractable
  • Screening Study
  • Uncertainty Factor
  • Alignment
  • Inconsistent Data

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Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 4-27; DOI: 10.5731/pdajpst.2024.012964

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