Table of Contents

Research

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  Pharmaceutical Manufacturing in the EU and the EU–US Mutual Recognition Agreement

  LÍgia Maria Gaspar Ernesto and Rui Miguel Dias Loureiro

  PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 617-626; DOI: https://doi.org/10.5731/pdajpst.2020.011437
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  Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products

  Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel

  PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379
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  Scalability of Sterilizing-Grade Filters in Different Filtration Modes

  Dippel Jannik, Handt Sebastian, Hansmann BjÖrn and Loewe Thomas

  PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 644-659; DOI: https://doi.org/10.5731/pdajpst.2019.011254
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  Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes

  Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann

  PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270
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  Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance

  Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao

  PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627