PDA Journal of Pharmaceutical Science and Technology

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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 October 2025, pdajpst.2024-003032.1; DOI: https://doi.org/10.5731/pdajpst.2024-003032.1
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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
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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
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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 Pachucki, 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 September 2025, pdajpst.2025-000023.1; DOI: https://doi.org/10.5731/pdajpst.2025-000023.1
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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
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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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Parenteral Drug Association, Inc.