PDA Journal of Pharmaceutical Science and Technology: 69 (3)

May/June 2015; Volume 69,Issue 3

Editorial

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Continuous Processing for Production of Biotech Therapeutics
Anurag S. Rathore

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 333; DOI: https://doi.org/10.5731/pdajpst.2015.01072

Commentary

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Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses
Jinshu Qiu, Kim Li, Karen Miller and Anil Raghani

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: https://doi.org/10.5731/pdajpst.2015.01056

Research

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Physicochemical Stability of Emulsions and Admixtures for Parenteral Nutrition during Irradiation by Glass-Filtered Daylight at Standardized Conditions
Marianne Lilletvedt Tovsen, Gro Smistad, Trude Marie Bjerke, Hanne Hjorth Tønnesen and Solveig Kristensen

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 346-354; DOI: https://doi.org/10.5731/pdajpst.2015.01036
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Microscopic Characterization of Brevundimonas diminuta in the Hydrated State
Gary Harp, Seok-Jun Cho, Elisabeth Lester, David Rose, Chandran Sabanyagam and Scott F. Ross

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 355-365; DOI: https://doi.org/10.5731/pdajpst.2015.01045
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A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies
Dennis Jenke, Norman Liu, Yousheng Hua, Steven Swanson and Roy Bogseth

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 366-382; DOI: https://doi.org/10.5731/pdajpst.2015.01046
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Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050
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Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín and Rolando Páez

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: https://doi.org/10.5731/pdajpst.2015.01052
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Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging
Wendy Shieu, Oliver B. Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 417-426; DOI: https://doi.org/10.5731/pdajpst.2015.01055

Technology/Application

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Practical Considerations for Detection and Characterization of Sub-Micron Particles in Protein Solutions by Nanoparticle Tracking Analysis
Flaviu Gruia, Arun Parupudi and Alla Polozova

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 427-439; DOI: https://doi.org/10.5731/pdajpst.2015.01051
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Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpike^TM Viruses
Philippe De Vilmorin, Ashley Slocum, Tareq Jaber, Oliver Schaefer, Horst Ruppach and Paul Genest

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 440-449; DOI: https://doi.org/10.5731/pdajpst.2015.01054

BPOG Special Section

Editorial
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  Introduction to BioPhorum Operations Group (BPOG) Special Section Editorials
  Darren Whitman
  
  PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 450; DOI: https://doi.org/10.5731/pdajpst.2015.01069
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  Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
  David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
  
  PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070
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  White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
  Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
  
  PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

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Parenteral Drug Association, Inc.