Buffers comprise an integral component of protein formulations. Not only do they function to
regulate shifts in pH, they also can stabilize proteins by a variety of mechanisms. The ability …

Recombinant proteins are the mainstay of biopharmaceuticals. A key challenge in the
manufacturing and formulation of protein biologic products is the tendency for the active …

Measurement of the average intensity of excess scattering, termed static light scattering
(SLS), has become one of the most widely used techniques for the determination of molar …

To ensure the stability of biologicals over their entire shelf-life, non-ionic surface-active
compounds (surfactants) are added to protect biologics from denaturation and particle …

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 …

With the rapid growth of biopharmaceutical product development, knowledge of therapeutic
protein stability has become increasingly important. We evaluated assays that measure …

Nano differential scanning fluorimetry (nanoDSF) is a high-throughput protein stability
screening technique that simultaneously monitors protein unfolding and aggregation …

Protein-based therapeutics have revolutionized the pharmaceutical industry and become
vital components in the development of future therapeutics. They offer several advantages …

So-called “weak” protein–protein interactions are important for the control of solution
properties and stability at elevated protein concentrations (c 2) but are not practical to …

At low protein concentrations (c 2), non-native protein aggregation rates are known to be
sensitive to changes in conformational stability and “weak” or “colloidal” protein–protein …