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

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 …

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

Peristaltic pumping during bioprocessing can cause therapeutic protein loss and
aggregation during use. Due to the complexity of this apparatus, root-cause mechanisms …

Processing stresses on therapeutic proteins may cause formation of subvisible particles.
Different stress mechanisms generate particle populations with characteristic morphological …

A survey performed by the AAPS Drug Product Handling community revealed a general,
mostly consensus, approach to the strategy for the selection of surfactant type and level for …

To better understand protein aggregation and inherent particle formation in the biologics
pipeline at Novartis, a cross-functional team collected and analyzed historical protein …

Processing equipment involving grinding of two solid surfaces has been demonstrated to
induce subvisible particle formation in monoclonal antibody drug product manufacturing …

Biologics manufacturing has seen many new developments in recent years. The industry is
moving away from processing systems based on stainless steel (with cleaning and …