Protein stability against aggregation is a major quality concern for the production of safe and
effective biopharmaceuticals. Amongst the different drivers of protein aggregation …

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 …

Intravitreal injections have become the most commonly performed intraocular treatments
worldwide. Because intravitreal injections may induce severe adverse events, such as …

Particles in biopharmaceutical products present high risks due to their detrimental impacts
on product quality and safety. Identification and quantification of particles in drug products …

Particles in biopharmaceutical formulations remain a hot topic in drug product development.
With new product classes emerging it is crucial to discriminate particulate active …

Peristaltic pumping can cause protein particle formation. The expected causes were
unfolding by heat in the pump head, oxidative stress by cavitation generated during roller …

A number of biopharmaceuticals are available as lyophilized formulations along with a
prefilled syringe (PFS) containing water for injection (WFI). Submicron-and micron-size …

Introduction Several new biopharmaceutical dosage forms have developed over time, such
as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review …

A novel approach to identify 5 types of simulated stresses that induce protein aggregation in
prefilled syringe–type biopharmaceuticals was developed. Principal components analyses …

Subvisible particles (SVPs) are a critical quality attribute of parenteral and ophthalmic
products. United States Pharmacopeia recommends the characterizations of SVPs which …