In a recent article, a U.K. group outlined their vision for downstream process analytic technology (PAT) and quality by design (QbD) within the context of batch vs. continuous chromatography. The ...

Traditionally, vaccine manufacture has accounted for a huge amount of aseptic production. In recent years, there has been a larger focus on novel biologic therapies, of which the majority are ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, guided by regulatory frameworks like FDA and ICH. Technological advances, ...

FT-NIR spectroscopy possesses a unique advantage when compared to other technologies in that they offer a real-time assessment of the process on a molecular basis. A FT-NIR process spectrometer MATRIX ...

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 ...

Stress variations in any cooling-water system bring about changes in the potential for scale, corrosion, and fouling. The ability to monitor the changing potential for these operational problems, ...