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 instability caused by exposure to external additives or severe stress may result in
different diseases. Of these diseases, many are triggered by protein misfolding and …

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 role in human health of therapeutic proteins in general, and monoclonal antibodies
(mAbs) in particular, has been significant and is continuously evolving. A considerable …

Given their safety and efficiency in protecting protein integrity, polysorbates (PSs) have been
the most widely used excipients for the stabilization of protein therapeutics for years. In …

Highlights•Proteins undergo spontaneous degradation during manufacturing and
storage.•Chemical modifications to proteins can influence physical stability.•Predictive tools …

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 …

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 …

Oxidation represents a major pathway for the chemical degradation of pharmaceutical
formulations. Few specific details are available on the mechanisms that trigger oxidation …