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 ...

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 ...

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, ...

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, ...

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 ...