Table of Contents

Research

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  Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals

  Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael Carrier and Mariam Khan

  PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 418-432; DOI: https://doi.org/10.5731/pdajpst.2018.008953
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  Sample Treatments That Solve Low Endotoxin Recovery Issues

  Masakazu Tsuchiya

  PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 433-442; DOI: https://doi.org/10.5731/pdajpst.2018.009464
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  Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process

  Devon Roshan Eisner, Aaron Hubbard, Kirk Eppler, Vassia Tegoulia and Yuh-Fun Maa

  PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 443-458; DOI: https://doi.org/10.5731/pdajpst.2019.009928
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  Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)

  Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Jonathan Cutting, Magali Barbaroux, Jean-Marc Cappia and Marie-Christine Menier

  PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 459-469; DOI: https://doi.org/10.5731/pdajpst.2018.009688
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  Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration

  John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe and Louise Bennett

  PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 470-486; DOI: https://doi.org/10.5731/pdajpst.2018.009605
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  Preventing Cross-Contamination during Lyophilization: GMP and Occupational Cleaning Requirements for Nonproduct and Indirect Product-Contact Parts

  Richard Denk, Andreas Flückiger, Hirokazu Kisaka, Stephan Krause, Reinhold Maeck, Lars Restetzki, Andreas Schreiner and Rico Schulze

  PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 487-495; DOI: https://doi.org/10.5731/pdajpst.2018.009530