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

Protein aggregation is known to occur under different stress conditions and displays a wide
variety of morphologies. In this work, the aggregation behavior of a monoclonal antibody (…

The objective of this study was to compare different agitation stress methods (stirring in
Reacti Vials TM versus horizontal shaking) in their effect on protein destabilization, to assess …

Concern around the lack of monitoring of proteinaceous subvisible particulates in the 0.1–10
mm range has been heightened (Carpenter et al., 2009, J Pharm Sci 98: 1202–1205), …

The purpose of this work was to study the mechanistic pathways of degradation of
polysorbates (PS) 20 and PS80 in parenteral formulations. The fate of PS in typical protein …

Purpose To study the potential impact of the degradation of Polysorbates (PS) 20 and 80 on
the stability of therapeutic proteins in parenteral formulations. Method First, degradation …

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 …

Proteins as amphiphilic, surface-active macromolecules, demonstrate substantial interfacial
activity, which causes considerable impact on their multifarious applications. A commonly …

The purpose of this work was to compare biophysical properties of different monoclonal
antibodies (mAbs). mAbs' theoretical isoelectric point (IEP) and theoretical net charge were …

Purpose The aim of the study is to evaluate Fourier-transform infrared spectroscopy (FTIR)
as an analytical tool for high-concentrated protein formulations. Methods FTIR is used to …