Bowman Cox
Executive Editor
Latest From Bowman Cox
BARDA Expands US Domestic Production Of Single-Use Systems For Vaccine Manufacturing
FlexBiosys wins award; others to follow. New capacity may also benefit manufacture of monoclonal antibodies and cell and gene therapies.
Communication Is Key In Adapting Production To Pandemic Component Supply Disruptions
US FDA is looking at risk-based approach for reporting changes in out-of-stock components such as plastic bioreactor bags, filters and tubing sets that are in short supply.
US FDA Must Assess Business Impact Of Final Interstate Compounding MOU, Court Rules
Summary judgment puts 20-year-old effort to define ‘inordinate’ out-of-state drug compounding back on slow track.
The Quality Lowdown: Corporate Culture And Site Complexity Can Pose Challenges
Quality and the measure of a firm: Toyobo’s particulates and resins, Galenicko’s sanitation, Breckenridge’s product chemistry and Fujifilm’s cross-contamination risk.
US FDA Board Formed To Manage Increasingly Complex Pharmaceutical Supply Chain Oversight
High-level board will bring together information from across FDA drug center and work to increase supply chain transparency, says CDER’s Jacqueline Corrigan-Curay.
US FDA’s Machine Learning Analysis Suggests Where To Look For Manufacturing Site Quality Problems
XGBoost model sees site complexity contributes to quality risk, but misses device-related issues, says third FDA pharmaceutical quality report.