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, ...

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 ...

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 ...

Julien Libeau is U.S. business development manager for WorldCast Systems. This is excerpted from a Radio World ebook on trends in remote control and facility management. Julien Libeau: The move toward ...

The Public Company Accounting Oversight Board[ has created three videos from its staff on its quality control standard explaining the monitoring and remediation process. Processing Content The ...

Particle size distribution (PSD) continues to be one of the most decision-critical variables in metal mining, impacting comminution efficiency, recovery, liberation, and tailings behavior. This ...