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 …

The subcutaneous administration route is widely used to administer different types of drugs
given its high bioavailability and rapid onset of action. However, the sensation of pain at the …

The aggregation of a polypeptide chain into amyloid fibrils and their accumulation and
deposition into insoluble plaques and intracellular inclusions is the hallmark of several …

The elicitation of anti-drug antibodies (ADA) against biotherapeutics can have detrimental
effects on drug safety, efficacy, and pharmacokinetics. The immunogenicity of …

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 …

Proteins generally will tend to aggregate under a variety of environmental conditions in
comparison with small drug molecules. The extent of aggregation is dependent on many …

The purpose of this review is to demonstrate the critical importance of understanding protein–
excipient interactions as a key step in the rational design of formulations to stabilize and …

Monoclonal antibodies have proved to be a highly successful class of therapeutic products.
Large‐scale manufacturing of pharmaceutical antibodies is a complex activity that requires …

Adsorption of proteins to fluid interfaces is critical in many industries, scientific disciplines,
and biological processes. However, the structural transitions of proteins upon adsorption …

ABSTRACT Within the European Immunogenicity Platform (EIP)(http://www. eip. eu), the
Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and …