PDA Journal of Pharmaceutical Science and Technology: 72 (4)

July/August 2018; Volume 72,Issue 4

Editor's Note

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PDA Forms Journal Editorial Board – Call for Volunteeers
Richard Levy

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 347; DOI: https://doi.org/10.5731/pdajpst.2018.001108

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Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality
Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 348-366; DOI: https://doi.org/10.5731/pdajpst.2017.008326
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Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
Alejandra Nieto and Holger Roehl

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 367-381; DOI: https://doi.org/10.5731/pdajpst.2017.008391
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Introducing the Alba^® Primary Packaging Platform. Part 1: Particle Release Evaluation
Alberto Chillon, Arianna Pace and Daniele Zuccato

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 382-392; DOI: https://doi.org/10.5731/pdajpst.2018.008623
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Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long-Term Stability of Monoclonal Antibodies
Lin M. Luis, Yuzhe Hu, Camellia Zamiri and Alavattam Sreedhara

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 393-403; DOI: https://doi.org/10.5731/pdajpst.2018.008581

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Ozone Generation during High-Voltage Leak Detection: Fiction or Reality?
Sophie Becker, Kai Reimers, Volker Bickert and Martin Becker

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 404-410; DOI: https://doi.org/10.5731/pdajpst.2016.007153
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Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals
Andrew N. Antoszyk, Carl Baker, Jorge Calzada, Howard Cummings, Joanna So, Carlos Quezada-Ruiz and Zdenka Haskova

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 411-419; DOI: https://doi.org/10.5731/pdajpst.2017.008342

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The Role of Heat-Tolerant Endotoxin-Retentive Ultrafilters (UFs) for the Remediation of Reverse Osmosis (RO) Plants Employed for Surgical Hand Antisepsis Using Periodic Thermal Disinfection—A Ten Year Longitudinal Experience Study in the Operating Theater
Yushi Uetera, Hiroshi Yasuhara, Naohito Kumada, Yoshiki Misawa, Yoshiyuki Terada, Yoshio Satou, Tamaki Suhara and Kunio Kawamura

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 420-437; DOI: https://doi.org/10.5731/pdajpst.2017.008482

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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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Erratum for John Mattila, Mike Clark, Shengjiang Liu, et al.: “Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration”
John Mattila, Mike Clark, Shengjiang Liu, John Pieracci, Thomas R. Gervais, Eileen Wilson, Olga Galperina, Xinfang Li, David Roush, Konstantin Zoeller, Helene Brough and Christelle Simpson-Platre

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 451; DOI: https://doi.org/10.5731/pdajpst.2017.007963