These models can be used either offline to provide the optimal process cycle, or online to provide optimal, real-time process control [3]. This is the target of the iREMO project (www.iremo.eu), an EC ...

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 ...

Reaching Bioprocessing 4.0 depends on advanced methods of monitoring and control. For an update on these methods, GEN has organized this roundtable discussion. It presents the insights of four experts ...

Polymers are organic materials that are characterized by unique properties, such as tensile strength and viscoelastic behavior under deformation. As a result, these materials are used extensively in ...

"The problem with paperwork is, if you had a 12-hour shift, you finish your paper work 11-and-a-half hours after that person started the machine," Gattshall explains. "That's the point where you look ...

RT-MALS can provide instantaneous measurements of adenovirus particle size and titer during downstream and fill–finish ...

With the continued need for shrinking pattern dimensions, semiconductor manufacturers continue to implement more complex patterning techniques, such as advanced multi-patterning, for the 10nm design ...

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 ...

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, ...