Yasser Nashed-Samuel

TL;DR: Protein aggregates can be a very heterogeneous population, whose qualities are the result of the type of stress that was experienced, and most classes showed a disruption of the higher order structure, with the degree of disorder depending on the stress process.

TL;DR: The aggregation was dependent on tungsten and protein concentration, and the ratio of these two and appears to arise through electrostatic interaction between protein and tundsten molecules.

TL;DR: Improved syringe barrel forming and washing processes at the supplier have lowered the residual tungsten content and significantly reduced the risk of protein aggregate formation, demonstrating that packaging component manufacturing processes, which are outside the direct control of drug manufacturers, can have an impact on the drug product quality.

TL;DR: It is shown that if a chemical compound formed by the breakdown of a common antioxidant additive to plastics leaches into the cell culture liquid, the growth of mammalian cells is strongly inhibited.

TL;DR: Overall, this issue represents a risk to the production of biopharmaceuticals in SUS, a risk that must be managed by diligent collaboration among companies along the entire supply chain for SUS components.