PDA Journal of Pharmaceutical Science and Technology: 79 (6)

November/December 2025; Volume 79,Issue 6

Editorial

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A New Era for the PDA Journal of Pharmaceutical Science and Technology
Michael Sadowski, Shanker Gupta, Ghada Haddad, Kurt Brorson and Whitney Alexis

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 564-567; DOI: https://doi.org/10.5731/pdajpst.2025-000077.1

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Use of the Retention Index to Secure Correct Identities in GC/MS
Piet Christiaens, Dennis Jenke, Jan Baeten, Philippe Verlinde and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 568-592; DOI: https://doi.org/10.5731/pdajpst.2025-000008.1
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Charting the Universe of Organic Extractables and Leachables: Compounds with Confirmed Identities
Dennis Jenke, Piet Christiaens, Adam Jenke, Jan Baeten, Philippe Verlinde and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 593-668; DOI: https://doi.org/10.5731/pdajpst.2025-000007.1
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Opportunities for Improvement in Managing pre-PPQ Biologic Product Knowledge
Beth Fulton, Theo Zacharatos, Igor Gorsky, Angelica Welch and James Vesper

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 669-681; DOI: https://doi.org/10.5731/pdajpst.2024-003032.1

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Digital Reference Materials: A New Standard for Quality and Compliance in Bio/Pharmaceutical Manufacturing
Vadim Klyushnichenko

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 682-685; DOI: https://doi.org/10.5731/pdajpst.2025-000039.1

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Strategy for Validation of New Mycoplasma Nucleic Acid Detection Closed System and It Use in Routine Biopharmaceutical Manufacturing
Caroline Kassim Houssenaly, Samad Amini-Bavil-Olyaee, Carlos Salas Chung, Chakameh Azimpour, Ryan Pachuki, Orm Niewenhuizen, Karen De Roy, Zhihua Liu, Berenice Westrek-Esselink, Celine Vanmasstright, Marine Marius and Felix Alejandro Montero Julian

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 686-693; DOI: https://doi.org/10.5731/pdajpst.2025-000023.1

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Considerations for the Validation of Non-CFU Based Bio-Fluorescent Particle Counting Technologies
Cynthia Martindale, Caroline Dreyer, Cedric Joossen, Joanny Salvas, Kim Perkins, Mike Dingle, Petra Merker, Philip Villari, Tony Cundell, Margit Franz-Riethdorf and Patrick Hutchins

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 694-706; DOI: https://doi.org/10.5731/pdajpst.2024-003036.1
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NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of Alternative and Rapid Microbiological Methods
Jennifer L. Mantle, Eugene Schaefer and Kelvin H. Lee

PDA Journal of Pharmaceutical Science and Technology November 2025, 79 (6) 707-718; DOI: https://doi.org/10.5731/pdajpst.2025-000026.1