Medical devices are an important and growing aspect of healthcare provision and are
increasing in complexity to meet established and emerging patient needs. Terminal …

Protein aggregation in biotherapeutics has been identified to increase immunogenicity,
leading to immune-mediated adverse effects, such as severe allergic responses including …

Protein pharmaceuticals have become a significant class of marketed drug products and are
expected to grow steadily over the next decade. Development of a commercial protein …

The reported impact of shear stress on protein aggregation has been contradictory. At high
shear rates, the occurrence of cavitation or entrapment of air is reasonable and their effects …

Protein degradation is a major concern for protein-based therapeutics. It may alter the
biological activity of the product and raise the potential for undesirable effects on the …

During their manufacturing and delivery to patients, therapeutic proteins are commonly
exposed to various interfaces and to hydrodynamic shear forces. Although adsorption of …

This work investigates the enrichment of bovine serum albumin (BSA) protein through foam
fractionation. Here, we performed experiments using BSA and measured the recovery and …

Oxidation represents a major pathway for the chemical degradation of pharmaceutical
formulations. Few specific details are available on the mechanisms that trigger oxidation …

In hospitals, often drug products in intravenous (IV) bags are transported via pneumatic tube
systems (PTS). The goal of this study was to evaluate the effects of such transportation of …

Aggregates and particles may be generated by positive displacement piston pumps during
fill-finishing operations for protein formulations. We investigated potential factors that might …