Table of Contents

May/June 2025; Volume 79,Issue 3

  1. Brehme, Franziska

    1. Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
      Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau and Ana Luisa Silva
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 295-302; DOI: https://doi.org/10.5731/pdajpst.2024-003023.1

  2. Burgwin, Chelsea

    1. Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration—Post ICH Q5A(R2) Review
      Jennifer Anderson, Chelsea Burgwin and Donna Hamilton
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 320-336; DOI: https://doi.org/10.5731/pdajpst.2024-003024.1

  3. Cetlin, David

    1. Viral Safety Reloaded—Insights from PDA’s Virus Conference Around the Finalized ICH Q5A (R2) and NGS Workshop
      Sebastian B. Teitz, Andy Bailey, Johannes Blümel, Arifa Khan, Alison Armstrong, Thomas R. Kreil, Tomoko Hongo-Hirasaki, Remo Leisi, David Cetlin, Chakameh Azimpour, Sean O’Donnel and Simone Olgiati
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 337-354; DOI: https://doi.org/10.5731/pdajpst.2025-000009.1

  4. Cullinan, Jackie L.

    1. Analysis of Virus Clearance for Biotechnology Manufacturing Processes from Early to Late Phase Development
      Opeyemi O. Ajayi, Jackie L. Cullinan, Innara Basria, Madaisabel Fuentes-Arias, Ashley Osuna-Najarro, Sarah Johnson, Talia Faison and Scott Lute
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 252-273; DOI: https://doi.org/10.5731/pdajpst.2025-000001.1

  5. Elabbasi, Nagi

    1. Coring and Fragmentation of Elastomeric Needle Shield in a Pre-Filled Syringe
      Sahab Babaee, Sean Teller, Kavin Kowsari, Nikolaos Vasios, Steven C. Persak, Nagi Elabbasi and Guangli Hu
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 274-284; DOI: https://doi.org/10.5731/pdajpst.2024-003041.1

  6. Faison, Talia

    1. Analysis of Virus Clearance for Biotechnology Manufacturing Processes from Early to Late Phase Development
      Opeyemi O. Ajayi, Jackie L. Cullinan, Innara Basria, Madaisabel Fuentes-Arias, Ashley Osuna-Najarro, Sarah Johnson, Talia Faison and Scott Lute
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 252-273; DOI: https://doi.org/10.5731/pdajpst.2025-000001.1

  7. Faure, Olivier

    1. Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
      Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau and Ana Luisa Silva
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 295-302; DOI: https://doi.org/10.5731/pdajpst.2024-003023.1

  8. Foubert, Michael W.

    1. Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
      Michael W. Foubert, Benoit Lux, Julie Bourguard, Lucas Schultz, Meng John Zhao, Jason D. Marlin, Matthew S. Huser, Henri Hebting and Lei Li
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 303-319; DOI: https://doi.org/10.5731/pdajpst.2024.012941

  9. Fuentes-arias, Madaisabel

    1. Analysis of Virus Clearance for Biotechnology Manufacturing Processes from Early to Late Phase Development
      Opeyemi O. Ajayi, Jackie L. Cullinan, Innara Basria, Madaisabel Fuentes-Arias, Ashley Osuna-Najarro, Sarah Johnson, Talia Faison and Scott Lute
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 252-273; DOI: https://doi.org/10.5731/pdajpst.2025-000001.1

  10. Graham, Jamie

    1. Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
      Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau and Ana Luisa Silva
      PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 295-302; DOI: https://doi.org/10.5731/pdajpst.2024-003023.1
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