Aggregation of Therapeutic Proteins

"Among their topics are fundamental structures and behaviors of proteins; protein aggregation pathways, kinetics, and thermodynamics; the identification and impact of aggregate-prone regions in proteins and therapeutic monoclonal antibodies; external factors affecting protein aggregation; experimental detection and characterization of protein aggregates; approaches to controlling it during bulk production; effects of formulation interfaces, and drug product manufacturing operations on aggregation and particle formation; approaches to managing it in product development; aggregation and immunogenicity of therapeutic proteins; and a regulatory perspective on aggregates as a product quality attribute." (SciTech Book News, December 2010)