A host of diverse stress techniques was applied to a monoclonal antibody (IgG 2 ) to yield
protein particles with varying attributes and morphologies. Aggregated solutions were …

Out of the plethora of chemical species extractable at low levels from the materials of construction
of single-use bioprocess containers, we have identified one particularly conspicuous …

Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study
probed the relationship between PFSs, tungsten, visible particles, and protein aggregates…

Particles isolated from a pre-filled syringe containing a protein-based solution were identified
as aggregated protein and tungsten. The origin of the tungsten was traced to the tungsten …

A current trend in the production of biopharmaceuticals is the replacement of fixed stainless
steel fluid‐handling units with disposable plastic bags. Such single‐use systems (SUS) offer …

The risk mitigation of extractables and leachables presents significant challenges to
regulators and drug manufacturers with respect to the development, as well as the lifecycle …

As the packaging of choice for many therapeutic proteins, prefilled syringes have been widely
used in biopharmaceutical industry as primary containers, where silicone oil is applied to …

… The condition of 70C for 4 days was calculated based on the Arrhenius equation, to
approximate 1 y of drug product storage at 5C, which indicates a 10C increase in temperature …

Leachables are chemical compounds that migrate from manufacturing equipment, primary
containers and closure systems, and packaging components into biopharmaceutical and …

Studies of the extractable profiles of bioprocessing components have become an integral
part of drug development efforts to minimize possible compromise in process performance, …