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 …

Abstract In 1989, Manning, Patel, and Borchardt wrote a review of protein stability (Manning
et al., Pharm. Res. 6: 903–918, 1989), which has been widely referenced ever since. At the …

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.• …

Control and analysis of protein aggregation is an increasing challenge to pharmaceutical
research and development. Due to the nature of protein interactions, protein aggregation …

Post-translational modifications (PTMs) can have profound effects on protein structure and
protein dynamics and thereby can influence protein function. To understand and connect …

The existence of multiple variants with differences in either charge, molecular weight or
other properties is a common feature of monoclonal antibodies. These charge variants are …

The survivability of viruses in natural and engineered systems impacts public health.
Inactivation mechanisms in the environment have been described for nonenveloped viruses …

The scope of this paper is to review approaches used for forced degradation (synonym,
stress testing) of therapeutic proteins. Forced degradation studies play a central role in the …

Therapeutic antibodies (IgG-type) contain several post-translational modifications (PTMs)
whereby introducing a large heterogeneity, both structural and functional, into this class of …

Loss of activity through aggregation and surface-induced denaturation is a significant
problem in the production, formulation and administration of therapeutic proteins …