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“