PDA Journal of Pharmaceutical Science and Technology: 69 (1)

January/February 2015; Volume 69,Issue 1

Review

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Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005

Research

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Extractables Analysis of Single-Use Flexible Plastic Biocontainers
Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001
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Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003
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Scale-up of Sterilizing-grade Membrane Filters from Discs to Pleated Cartridges: Effects of Operating Parameters and Solution Properties
Anil Kumar, Jerold Martin and Ralf Kuriyel

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 74-87; DOI: https://doi.org/10.5731/pdajpst.2015.01006
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A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

Technology/Application

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Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007

Case Studies

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Non-Destructive Vacuum Decay Method for Pre-Filled Syringe Closure Integrity Testing Compared with Dye Ingress Testing and High-Voltage Leak Detection
Andrea Simonetti and Filippo Amari

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 108-122; DOI: https://doi.org/10.5731/pdajpst.2015.01004

PDA Paper

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Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

Proceedings of the 2013 Viral Clearance Symposium

Conference Proceeding
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  Proceedings of the 2013 Viral Clearance Symposium (Princeton, NJ)
  David Roush, Kurt Brorson and Rich Levy
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 140-141; DOI: https://doi.org/10.5731/pdajpst.2015.01053
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  Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
  Qi Chen and Dayue Chen
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 142-153; DOI: https://doi.org/10.5731/pdajpst.2015.01038
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  Viral Clearance Using Traditional, Well-Understood Unit Operations: Session 1.2. Anion Exchange Chromatography; and Session 1.3. Protein A Chromatography
  David Roush
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 154-162; DOI: https://doi.org/10.5731/pdajpst.2015.01039
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  Viral Inactivation: Low pH and Detergent
  Laura Durno and Omar Tounekti
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 163-172; DOI: https://doi.org/10.5731/pdajpst.2015.01040
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  Session 1.5: Other Viral Clearance and Inactivation Approaches (Multimodal Chromatography, Membrane Chromatography, Chemical Precipitation)
  Brian Hubbard
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 173-182; DOI: https://doi.org/10.5731/pdajpst.2015.01041
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  Session 2/3: Integrated Viral Clearance Strategy and Case Studies
  Hannelore Willkommen
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 183-194; DOI: https://doi.org/10.5731/pdajpst.2015.01042
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  Session 4: Overall Integrated Viral Clearance and Adventitious Agents Strategy
  Johannes Blümel and Omar Tounekti
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 195-205; DOI: https://doi.org/10.5731/pdajpst.2015.01043
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  2013 Viral Clearance Symposia - Session 5. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments
  Johannes Blümel and David Roush
  
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 206-210; DOI: https://doi.org/10.5731/pdajpst.2015.01044
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  Appendix: Organizers, Participants and Contributors of the 2013 Viral Clearance Symposia
  PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 211-212; DOI: https://doi.org/10.5731/pdajpst.2015.01047

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Parenteral Drug Association, Inc.