Long-term stability of monoclonal antibodies to be used as biologics is a key aspect in their
development. Therefore, its possible early prediction from accelerated stability studies is of …

The formulation development of monoclonal antibodies is extremely challenging, due to the
diversity and complexity contained within this class of molecules. The physical and chemical …

Monoclonal antibodies are the fastest growing class of therapeutics. However, aggregation
limits their shelf life and can lead to adverse immune responses. Assessment and …

With the rapid growth of biopharmaceutical product development, knowledge of therapeutic
protein stability has become increasingly important. We evaluated assays that measure …

It is of particular interest for biopharmaceutical companies developing and distributing fragile
biomolecules to warrant the stability and activity of their products during long-term storage …

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 …

With more than 90 approved drugs by 2020, therapeutic antibodies have played a central
role in shifting the treatment landscape of many diseases, including autoimmune disorders …

Understanding the pharmacokinetic (PK) properties of a drug, such as clearance, is a crucial
step for evaluating efficacy. The PK of therapeutic antibodies can be complex and is …

An antibody's stability greatly influences its performance (ie its specificity and affinity). Thus,
stability is a major issue for researchers and manufacturers, especially with the increasing …

Monoclonal antibodies are proteinaceous in nature and are subject to instability issues.
Stability testing of monoclonal antibodies is a critical regulatory requirement in their …