Subvisible particle formation, rubber stopper seal performance, and antigen adsorption are some of the latest research topics in the March/
April issue of the PDA Journal of Pharmaceutical Science and Technology.
Review
Anil K. Rattan, “Data Integrity: History, Issues, and Remediation of Issues“
Research
Yuh-Fun Maa, et al., “Mechanistic Investigation on Grinding-
Induced Subvisible Particle Formation during Mixing and Filling of
Monoclonal Antibody Formulations“
Qingyu Zeng, Xia Zhao, “Time-Dependent Testing Evaluation and
Modeling for Rubber Stopper Seal Performance“
Patrick L. Ahl, et al., “Quantitative Analysis of Vaccine Antigen
Adsorption to Aluminum Adjuvant Using an Automated High-
Throughput Method“
Ganapathy Gopalrathnam, et al., “Impact of Stainless Steel Exposure
on the Oxidation of Polysorbate 80 in Histidine Placebo and Active
Monoclonal Antibody Formulation“
Case Studies
Laurent Siret, et al., “Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design—A
Worked through Case Study“
Technology/Application
Daniel Coleman, et al., “A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry“
Tony Cundell, David Jones, “Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration“
Commentary
Derek Willison-Parry, et al., “Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective“