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May/June Issue of Journal Looks at Sterile Production Gap

May 01, 2017

James Agalloco looks at the latest research in how the sterile production gap impacts patient safety in the May/June issue of the PDA Journal of Pharmaceutical Science and Technology.

Review

James P. Agalloco, “Increasing Patient Safety by Closing the Sterile Production Gap – Part 1 - Introduction“

James P. Agalloco, “Increasing Patient Safety by Closing the Sterile Production Gap – Part 2 - Implementation“

Research

Yuh-Fun Maa, et al., “Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress“

Fernando A. Garcia, Michael W. Vandiver, “Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities“

Marcel Goverde, Oliver Gordon, Alexandra Staerk, David Roesti, “Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products“

Technology/Application

Ildikó Ziegler, et al., “Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study"

Commentary

Mostafa Essam Eissa, “Quantitative Microbial Risk Assessment of Pharmaceutical Product”

PDA Paper

Emma Ramnarine, et al., “PDA Points to Consider: Technical Product Lifecycle Management: Pharmaceutical Quality System Effectiveness For Managing Post-Approval Changes“

Conversations

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