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PDA Journal of Pharmaceutical Science and Technology

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Frederick D. Simon Paper of the Year

Each year, PDA presents the Frederick D. Simon Award for the best paper published in the PDA Journal of Pharmaceutical Science and Technology. The award is named in honor of the late Frederick D. Simon, a former PDA Director of Scientific Affairs, and is presented to recipients at the PDA Annual Meeting.  

Below are the last ten award-winning papers. 

Year 

Winner(s) 

Article 

2018 

Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, and Yuh-Fun Maa 

“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,” July/August 2018 

2017 

Christopher Timmons, Chi Yuen Liu, and Stefan Merkle 

“Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial,” September/October 2017 

2016 

Patricia Cash, Stephan Krause, Sophia Levitskaya-Seaman, Maryam Mazaheri, Derek Murphy, and Roja Narwal 

“Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products,” March/April 2016 

2015 

Mayumi Bowen, Benson Gikanga, Ada Hui, Yuh-Fun Maa, Oliver B. Stauch, and Robert Turok 

“Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale,” January/February 2015  

2014 

Yuh-Fun Maa, Wendy Shieu, Sarah Torhan, Edwin Chan, Aaron Hubbard, Benson Gikanga, and Oliver Stauch 

“Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: Filling Parameter Investigation and Optimization,” March/April 2014 

2013 

Xiaolin Cao, Gregory S. Stimpfl, Zai-Qing Wen, Gregory T. Frank, and Glenn Hunter 

“Identification and Root Cause Analysis of Cell Culture Media precipitates in the Viral Deactivation Treatment with High-Temperature/Short-Time Method,” January/February 2013 

2012 

James A. Melchore 

“Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection,” May/June 2012 

2011 

Guenther Gapp and Peter Holzknecht 

“Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach,” May/June 2011 

2010 

Wei Liu, Rob Swift, Gianni Torraca, Yasser Nashed-Samuel, Zai-Qing Wen, Yijia Jiang, Aylin Vance, Anthony Mire-Sluis, Erwin Freund, Janice Davis, and Linda Narhi  

“Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes,” January/February 2010 

2009 

Bruce Eu, Xiaolin Cao, Aylin Vance, Fabian Vega, Robert Schultheis and Zai-Qing Wen 

“Distribution of Silicone Oil in Prefilled Glass Syringes Probed with Optical and Spectroscopic Methods,” March/April 2009 

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