United States
ProteoStat® Protein Aggregation Assay
Selected Literature
ProteoStat® Protein Aggregation Assay Flyer
Biochemical assays for monitoring protein aggregates often rely upon ultracentrifugation, size-exclusion chromatography, gel electrophoresis, dynamic light scattering, or turbidity measurements. These techniques are not capable of working for every protein, nor are the assays ideal for tackling the wide range of aggregation problems that can arise during the manufacture of protein pharmaceuticals.
ProteoStat® Protein Aggregation Assay provides a simple, homogenous assay format for monitoring peptide and protein aggregation. The assay can be employed to streamline protein processing and optimize formulation procedures from protein expression through manufacturing. Relative to conventional protein aggregation detection dyes, such as Thioflavin T, ProteoStat® Detection Reagent can detect a broader range of different protein aggregates. The assay yields a much brighter signal, provides at least 2 orders of magnitude linear dynamic range, and offers superior performance across a broad range of pH values (4~10) and buffer compositions. Sensitivity of this assay is in the sub-micro-molar range and as less than 1% protein aggregate is detectable in a protein solution. The assay delivers Z’ factor scores greater than 0.5, therefore, providing quantitative analysis of protein aggregation in a robust and high-throughput fashion. Lyophilized native and aggregated proteins are provided as negative and positive controls for monitoring changes in protein aggregation status.
- A simple, sensitive, homogenous fluorescent microplate assay in a convenient mix-and-read format
- Ability to detect a very broad range of different protein aggregates from visible to subvisible
- Works over a wide pH and ionic strength range and is compatible with commonly used buffers and excipients
- Provides a convenient, complementary orthogonal method for cross-validation of instrumentation-intensive techniques
- Useful assay to troubleshoot protein damage from protein expression through manufacturing stages
ProteoStat® Protein Aggregation Standards kit is the only commercially available protein aggregation standards assay with stabilized, high-quality reference samples for generating trace protein aggregate levels in concentrated monomeric IgG.
Easy to use - simply add water!
Protein A EIA Kit is a sensitive, accurate, and reproducible sandwich assay to measure natural and recombinant Protein A residuals in monoclonal antibody preparations. The Protein A EIA kit has been extensively validated in humanized IgG preparations to ensure accurate recovery and sensitivity.
