Protein aggregation has been recognized as one of the major challenges in the
development and commercialization of successful protein-based drug products because of …

Although it is well known that proteins are only marginally stable in their folded states, it is
often less well appreciated that most proteins are inherently aggregation-prone in their …

Size exclusion chromatography (SEC) is a historical technique widely employed for the
detailed characterization of therapeutic proteins and can be considered as a reference and …

Highlights•Proteins aggregate in a variety of ways, most of which are unwanted in drug
products.•Possible impacts on product quality include deliverability and immunogenicity.• …

In this review, we attempt to give a concise overview of recent progress made in mechanistic
understanding of protein aggregation, particulate formation and protein solution rheology …

Changes in protein–protein interactions, protein unfolding, and nonnative aggregation were
assessed for a series of human IgG1 antibodies as a function of pH and solution ionic …

In this work, different thermal aggregation behaviors of soy β-conglycinin and glycinin at pH
7.0 were characterized with size exclusion chromatography and low-angle light scattering …

Protein aggregation presents one of the key challenges in the development of protein
biotherapeutics. It affects not only product quality but also potentially impacts safety, as …

Non-native aggregation is a common concern during therapeutic protein product
development and manufacturing, particularly for liquid dosage forms. Because aggregates …

Protein-protein interactions (PPI) and solution viscosities were measured at low and high
protein concentrations under a range of formulation conditions for 4 different monoclonal …