To assure patient safety, biologics developers and manufacturers must carefully consider where contaminants could be introduced to the drug substances (DSs) or drug products (DPs) at all stages of the ...

This article outlines improvements and changes to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which during aseptic processing, is a regulatory ...

Limited remote, continuous measurement and poor instrument/software interconnectivity impede manufacturing management (enterprise) system deployment and restrict the use of analytical results for real ...

Why is aseptic processing important in pharmaceutical manufacturing? The manufacturing of both sterile drugs and biological products can be achieved through terminal sterilization or aseptic ...