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Case ReportCase Studies

The Use of Amplified ATP Bioluminescence for Rapid Sterility Testing of Drug Product Formulations

Miriam Guest, Benjamin Pickard, Benjamin Smith and Sophie Drinkwater
PDA Journal of Pharmaceutical Science and Technology September 2023, 77 (5) 402-411; DOI: https://doi.org/10.5731/pdajpst.2022.012762
Miriam Guest
AstraZeneca, Cheshire, SK10 2NA, England
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  • For correspondence: Miriam.guest@crl.com
Benjamin Pickard
AstraZeneca, Cheshire, SK10 2NA, England
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Benjamin Smith
AstraZeneca, Cheshire, SK10 2NA, England
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Sophie Drinkwater
AstraZeneca, Cheshire, SK10 2NA, England
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Article Information

vol. 77 no. 5 402-411
DOI 
https://doi.org/10.5731/pdajpst.2022.012762
PubMed 
37321864

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 6, 2023.

Article Versions

  • previous version (June 15, 2023 - 12:15).
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© PDA, Inc. 2023

Author Information

  1. Miriam Guest*,
  2. Benjamin Pickard,
  3. Benjamin Smith and
  4. Sophie Drinkwater
  1. AstraZeneca, Cheshire, SK10 2NA, England
  1. ↵*Corresponding Author: New Modalities and Parenteral Development, Pharmaceutical Technology and Development, Operations, AstraZeneca, S42, Redesmere, Macclesfield Campus, SK10 2NA, England; Telephone: +447384807069; E-mail: Miriam.guest{at}crl.com
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PDA Journal of Pharmaceutical Science and Technology: 77 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 5
September/October 2023
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The Use of Amplified ATP Bioluminescence for Rapid Sterility Testing of Drug Product Formulations
Miriam Guest, Benjamin Pickard, Benjamin Smith, Sophie Drinkwater
PDA Journal of Pharmaceutical Science and Technology Sep 2023, 77 (5) 402-411; DOI: 10.5731/pdajpst.2022.012762

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The Use of Amplified ATP Bioluminescence for Rapid Sterility Testing of Drug Product Formulations
Miriam Guest, Benjamin Pickard, Benjamin Smith, Sophie Drinkwater
PDA Journal of Pharmaceutical Science and Technology Sep 2023, 77 (5) 402-411; DOI: 10.5731/pdajpst.2022.012762
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  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Sterility Testing
    • Results
    • Discussion
    • Conclusion
    • Conflict of Interest Declaration
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    • References
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  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
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Keywords

  • Rapid microbiology methods
  • Sterility testing
  • Rapid sterility testing
  • Sterility assurance
  • Microbial identification
  • Dermacoccus nishinomiyaensis

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