Table of Contents

March/April 2020; Volume 74,Issue 2

  1. Sawant, Anil

    1. Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
      Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239

  2. Shaw, David

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  3. Singer, Donald

    1. Risk Assessment Approach to Microbiological Controls of Cell Therapies
      Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546

  4. Stevens, Jennitte

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  5. Sunasara, Khurram

    1. Control Strategy Approach for a Well-Characterized Vaccine Drug Product
      Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
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