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PDA Journal of Pharmaceutical Science and Technology

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Accepted Articles

Each month, PDA Journal of Pharmaceutical Science and Technology publishes articles accepted for publication in advance to final issue designation, with the permission of the authors. Accepted Articles are the unedited, unformatted manuscripts that are accepted by the Editor-in-Chief following a successful peer-review. These drafts will be removed from Accepted Articles when the final and typeset version of record are published in an issue of the journal. 
 

To see an article, click its [PDF] link. To review many abstracts, check the boxes to the left of the titles you want, and click the 'Get All Checked Abstract(s)' button. To see one abstract at a time, click its [Abstract] link.

January 30, 2026

  • You have access
    A QbD Framework for Efficient Technology Transfer in Biologics Manufacturing
    Dogan Ornek
    PDA Journal of Pharmaceutical Science and Technology January 2026, pdajpst.2025-000074.1; DOI: https://doi.org/10.5731/pdajpst.2025-000074.1
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    Neural Network Prediction of Response Factors for Extractables and Leachables in Pharmaceuticals and Medical Devices
    Yuanlin Deng, Anthony Grice, Michael Louis, Kaitlin Lerner and Kevin Rowland
    PDA Journal of Pharmaceutical Science and Technology January 2026, pdajpst.2025-000061.1; DOI: https://doi.org/10.5731/pdajpst.2025-000061.1
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    Non-sterile Drug Products - Microbiologically Related Recalls and Compliance Issues
    Edward C. Tidswell
    PDA Journal of Pharmaceutical Science and Technology January 2026, pdajpst.2025-000058.1; DOI: https://doi.org/10.5731/pdajpst.2025-000058.1

January 18, 2026

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    Reproducible and Efficient Phenotyping for Cell Therapy Manufacturing Using the Accellix Automated Flow Cytometer Platform
    Jacob Van Vloten, Seungmi Yoo, Gurleen Sandhu, Leah Teschner, Dinh Nguyen, Elaine Than, Rey Mali, Donna Rill, Chris Ayers and Felix A. Montero Julian
    PDA Journal of Pharmaceutical Science and Technology January 2026, pdajpst.2025-000035.1; DOI: https://doi.org/10.5731/pdajpst.2025-000035.1
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    Integrating real-time viable biofluorescent particle counters within robotic gloveless isolators
    Noel Long, Manny Khera and Bobby Lumia
    PDA Journal of Pharmaceutical Science and Technology January 2026, pdajpst.2025-000032.1; DOI: https://doi.org/10.5731/pdajpst.2025-000032.1
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    Proactive replacement in aseptic manufacturing: A Health Index + Weibull/Kaplan–Meier framework
    SaiVijay Thattukolla and SaiVinay Thattukolla
    PDA Journal of Pharmaceutical Science and Technology January 2026, pdajpst.2025-000055.1; DOI: https://doi.org/10.5731/pdajpst.2025-000055.1
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    Overcoming device component-related challenges and risks in prefilled syringe development
    Bettine Boltres, Fran deGrazio and Susan Neadle
    PDA Journal of Pharmaceutical Science and Technology January 2026, pdajpst.2025-000062.1; DOI: https://doi.org/10.5731/pdajpst.2025-000062.1

December 16, 2025

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    Ode to a Sporicide - Can we do better?
    Terra Kremer and Donald C Singer
    PDA Journal of Pharmaceutical Science and Technology December 2025, pdajpst.2025-000042.1; DOI: https://doi.org/10.5731/pdajpst.2025-000042.1
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    The European Qualified Person: Legal Accountability, Quality Leadership, and AI Integration in Modern Pharmaceutical Manufacturing
    Mario Stassen
    PDA Journal of Pharmaceutical Science and Technology December 2025, pdajpst.2025-000067.1; DOI: https://doi.org/10.5731/pdajpst.2025-000067.1
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    Development of Probabilistic Model to Predict Residual Seal Force of Crimped Vial Seals
    DanaLouise Cabrita, George Currier, Anthony Petrella, Bereket Yohannes, Jazz Honegger, Ankur Kulshrestha, Srini Sridharan, Yusuf Oni and Elizabeth Moroney
    PDA Journal of Pharmaceutical Science and Technology December 2025, pdajpst.2025-000041.1; DOI: https://doi.org/10.5731/pdajpst.2025-000041.1

November 24, 2025

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    Variability Assessment Methods for Lyophilized Drug Product, A Case Study
    Ajay Babu Pazhayattil, Marzena Ingram, Prasanna Sagar, Kishorkumar Kotini, Abhijit Bodhe, Mallinath Harwalkar, Satish Joshi, Subrata Chakraborty, Rajesh Sreedharan Nair and Ahmed Shaaban Elsaid
    PDA Journal of Pharmaceutical Science and Technology November 2025, pdajpst.2025-000046.1; DOI: https://doi.org/10.5731/pdajpst.2025-000046.1
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    AI and ATMP: Patients First
    Toni Manzano and William Whitford
    PDA Journal of Pharmaceutical Science and Technology November 2025, pdajpst.2025-000052.1; DOI: https://doi.org/10.5731/pdajpst.2025-000052.1
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    PAT Implementation - Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products.
    Tony Cundell
    PDA Journal of Pharmaceutical Science and Technology November 2025, pdajpst.2025-000044.1; DOI: https://doi.org/10.5731/pdajpst.2025-000044.1
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    A Discussion of Relevant and Meaningful Extraction Solvents for Extractables Testing of Implanted Medical Devices
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology November 2025, pdajpst.2025-000056.1; DOI: https://doi.org/10.5731/pdajpst.2025-000056.1

October 16, 2025

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    Challenges for Visual Inspection and Particle Control in Cell Therapy Products
    Roman Mathaes, Antonio Burazer, Satish K. Singh, John G. Shabushnig and Atanas Koulov
    PDA Journal of Pharmaceutical Science and Technology October 2025, pdajpst.2025-000021.1; DOI: https://doi.org/10.5731/pdajpst.2025-000021.1

October 14, 2025

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    The Emerging Role of Regulatory Intelligence in Biotechnology: An Integrated Literature Review of Strategic Compliance and Innovation Framework
    Jason Kerr, Mara Girgis, Immanuel Jason Victor, Leonardo Tavormina and Nigel D Reed
    PDA Journal of Pharmaceutical Science and Technology October 2025, pdajpst.2025-000034.1; DOI: https://doi.org/10.5731/pdajpst.2025-000034.1

September 17, 2025

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    A Guide to Navigating Quality Control Requirements for Alternative and Rapid Microbial Methods in Sterility and Mycoplasma Testing Across the Asia Pacific Region
    Juliana Gutierrez
    PDA Journal of Pharmaceutical Science and Technology September 2025, pdajpst.2024-003031.1; DOI: https://doi.org/10.5731/pdajpst.2024-003031.1
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    Establishment of Limit of In Vitro Cell Age (LIVCA) for Biologics Manufacturing Process
    Barbara Tevelev, Sharyn Farnsworth, Sarah Kaminsky-Pontell, Urška Verbovšek and Guanghua (Benson) Li
    PDA Journal of Pharmaceutical Science and Technology September 2025, pdajpst.2025-000013.1; DOI: https://doi.org/10.5731/pdajpst.2025-000013.1

July 15, 2025

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    Defining a Generic Technology Transfer Process for use Across the Biopharmaceutical Manufacturing Industry
    Jonathan Moore, Diana Chinchilla-Olszar, Mary Switzer, David Nellis, Dan Lasko, Ruth de la Fuente Sanz, Carrington Edmunds, Gene Schaeffer, Alex Gadberry, Jennifer Nicole Earley, Mithun N Thimonthy and Kelvin H. Lee
    PDA Journal of Pharmaceutical Science and Technology July 2025, pdajpst.2024-003037.1; DOI: https://doi.org/10.5731/pdajpst.2024-003037.1

Accepted Articles publish to this page on or about the 15th of each month.

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© 2026 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

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