Purpose To develop an analytical platform for the estimation as well as characterization of
aggregates over the complete size spectrum (from invisible monomer to visible precipitates) …

Global aggregation behaviors of three distinct monoclonal antibodies were characterized by
high throughput, multiassay analysis. First, extensive screening of formulations was …

Aggregation of mAbs is a crucial concern with respect to their safety and efficacy. Among the
various properties of protein aggregates, it is emerging that their size can potentially impact …

Understanding antibody aggregation is of great significance for the pharmaceutical industry.
We studied the aggregation of five different therapeutic monoclonal antibodies (mAbs) with …

Purpose Characterization of the monoclonal antibody aggregation process and identification
of stability factors that could be used as indicators of aggregation propensity with an …

The objective of this study was to evaluate microflow imaging (MFI) as a sensitive tool to
detect and quantify subvisible particle formation during freeze-thawing of an IgG 2 …

The evaluation of a dual wavelength size exclusion high performance liquid
chromatography (DW-SE-HPLC) method with improved sensitivity to detect aggregates in a …

Selecting optimal formulation conditions for monoclonal antibodies for first time in human
clinical trials is challenging due to short timelines and reliance on predictive assays to …

Aggregation of therapeutic proteins is a major concern as aggregates lower the yield and
can impact the efficacy of the drug as well as the patient's safety. It can occur in all …

The early-stage assessment of the physical stability of new monoclonal antibodies in
different formulations is often based on high-throughput techniques that suffer from various …