The subvisible and visible particles present in a solution are often classified based on size,
and are quantified by the actual number of particles present rather than by weight or molar …

… Shawn Cao is the subject expert for particles and aggregates analysis and he contributed
to the authoring and reviewing of this manuscript. Scott Kuhns is the subject expert for …

Polysorbates (PS) are widely used as a stabilizer in biopharmaceutical products. Industry
practices on various aspects of PS are presented in this part 1 survey report based on a …

ABP 215 is a biosimilar product to bevacizumab. Bevacizumab acts by binding to vascular
endothelial growth factor A, inhibiting endothelial cell proliferation and new blood vessel …

Measurement and characterization of subvisible particles (including proteinaceous and non-proteinaceous
particulate matter) is an important aspect of the pharmaceutical development …

Polysorbate (PS) 20 and 80 are the main surfactants used to stabilize biopharmaceutical
products. Industry practices on various aspects of PS based on a confidential survey and …

Subvisible particles (SbVPs) are a critical quality attribute for biotherapeutics. Particle content
in prefilled syringes (PFSs) of a biotherapeutic can include protein particles and silicone oil …

Field flow fractionation (FFF) is a technique that holds great promise for the analysis and
characterization of protein aggregates and particles, due to its wide dynamic range and matrix-…

Silicone oil is a lubricant for prefilled syringes (PFS), a common primary container for
biotherapeutics. Silicone oil particles (SiOP) shed from PFS are a concern for patients due to their …

One of the major product quality challenges for injectable biologics is controlling the amount
of protein aggregates and particles present in the final drug product. This article focuses on …