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

It has been over four decades since the development of monoclonal antibodies (mAbs)
using a hybridoma cell line was first reported. Since then more than thirty therapeutic …

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 …

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 …

Large-molecule antibody biologics have revolutionized medicine owing to their superior
target specificity, pharmacokinetic and pharmacodynamic properties, safety and toxicity …

Screening for pharmaceutically viable stability from measurements of thermally induced
protein unfolding and short-term accelerated stress underpins much molecule design …

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 …

Stabilization and formulation of therapeutic proteins against physical instability, both
structural alterations and aggregation, is particularly challenging not only due to each …