Monoclonal antibodies (mAbs) are subject to instability issues linked to their protein nature.
In this work, we review the different mechanisms that can be linked to monoclonal antibodies …

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 …

Biologic products encounter various types of interfacial stress during development,
manufacturing, and clinical administration. When proteins come in contact with vapor–liquid …

An observation of visible particulate matter was made during formulation development of a
mAb and investigations initiated to understand the colloidal instability of the formulation. It …

The safety and efficacy of protein pharmaceuticals depend not only on biological activity but
also on purity levels. Impurities may be process related because of limitations in …

Detection and characterization of particles in the visible and subvisible size range is critical
in many fields of industrial research. Commercial particle analysis systems have proliferated …

IgG1 mAb solutions were prepared with and without sodium chloride and subjected to
different environmental stresses. Formation of aggregates and particles of varying size was …

The purpose of this work was to determine the aqueous solubilities at 2–8° C of the major
free fatty acids (FFAs) formed by polysorbate 20 (PS20) degradation and identify possible …

Evaluating the in-use stability of a biological product including its compatibility with
administration components allows to define handling instructions and potential hold times …

Adsorption of antibody therapeutics to air–liquid interfaces can enhance aggregation,
particularly when the solution does not contain protective surfactant or when the surfactant is …