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 …

The use of biopharmaceuticals dates from the 19th century and within 5-10 years, up to 50%
of all drugs in development will be biopharmaceuticals. In the 1980s, the biopharmaceutical …

L-Asparaginase (ASNase) is a vital component of the first line treatment of acute
lymphoblastic leukemia (ALL), an aggressive type of blood cancer expected to afflict over …

Protein aggregation remains a major area of focus in the production of monoclonal
antibodies. Improving the intrinsic properties of antibodies can improve manufacturability …

Increasing attention has been paid to developability assessment with the understanding that
thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid …

Therapeutic antibody technology heavily dominates the biologics market and continues to
present as a significant industrial interest in developing novel and improved antibody …

The aggregation of biotherapeutics is a major hindrance to the development of successful
drug candidates; however, the propensity to aggregate is often identified too late in the …

Aggregation can be thought of as a form of protein folding in which intermolecular
associations lead to the formation of large, insoluble assemblies. Various types of …

Successful antibody development requires both functional binding and desirable
biophysical characteristics. In the current study, we analyze the causes of one hurdle to …