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Fidelity to Science & Correct Scientific Vocabulary—Microbial Control Versus Contamination Control
Edward C. Tidswell, Radha Tirumalai and David Hussong

PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 510-516; DOI: https://doi.org/10.5731/pdajpst.2018.009795
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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 September 2019, pdajpst.2018.009316; DOI: https://doi.org/10.5731/pdajpst.2018.009316
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The Bugs Don't Lie
James P Agalloco

PDA Journal of Pharmaceutical Science and Technology September 2019, pdajpst.2019.009894; DOI: https://doi.org/10.5731/pdajpst.2019.009894
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IDENTIFICATION AND QUANTITATION CLASSIFICATIONS FOR EXTRACTABLES AND LEACHABLES
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology August 2019, pdajpst.2019.010538; DOI: https://doi.org/10.5731/pdajpst.2019.010538
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What Does It Really Look Like to Properly Address a “Human Error Problem” in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance
Clifford Berry, Brian Chviruk, Danny Hernandez, Matt Beaugard, Kelly B. Stevens, Joe Polizzotto, Lene Bjerregaard and Daan Purbrick

PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 391-400; DOI: https://doi.org/10.5731/pdajpst.2018.009621
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Biopharmaceutical Industry Practices for Sequence Variant Analyses of Recombinant Protein Therapeutics
John Valliere-Douglass, Lisa Marzilli, Aparna Deora, Zhimei Du, Luhong He, Sampath Kumar, Yan-Hui Liu, Hans Martin-Mueller, Charles Nwosu, John Stults, Yan Wang, Sam Yaghmour and Yizhou Zhou

PDA Journal of Pharmaceutical Science and Technology June 2019, pdajpst.2019.010009; DOI: https://doi.org/10.5731/pdajpst.2019.010009
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How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 181-190; DOI: https://doi.org/10.5731/pdajpst.2018.008938
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Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing
Paul W. Barone, Stephen Avgerinos, Rob Ballard, Audrey Brussel, Philip Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mullberg, Marie Murphy, Kerstin Nöske, Sandi Parriott, Bonnie Shum, Michael E. Wiebe and Stacy L. Springs

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 191-203; DOI: https://doi.org/10.5731/pdajpst.2018.008862
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Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations
John D. Ayres

PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 626-639; DOI: https://doi.org/10.5731/pdajpst.2018.008615
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Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development
Kyle Zingaro, David Shaw, Jerry Carson, Anke Mayer-Bartschmid, Christian Bender, Christina Alves, Duncan Mcvey, Nan-Xin Qian, Qingxiang Wei, Michael W. Laird, Yuan Zhu, Robyn Emmins, John A. Follit, Alison Porter, Andrew J. Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Hervé Broly, Frank Lee, Matthew Reeser, Jared Spidel, Karin Anderson, Christine Demaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R. Kumar and Tony Gill

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 438-450; DOI: https://doi.org/10.5731/pdajpst.2018.008789

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Parenteral Drug Association, Inc.