A Novel Protein Aggregation Assay For Biologics Formulation Studies And Production QA/QC

By Peter Banks, BioTek Instruments, Inc., Winooski, Vermont; Wayne Patton and Dee Shen, Enzo Life Sciences, Farmingdale, New York

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 formulation development and the manufacture of protein pharmaceuticals. ProteoStat® Protein aggregation assay provides a simple, homogenous assay workflow for monitoring protein aggregation in a microplate assay format. The assay can be employed to streamline protein processing and optimize formulation procedures. Relative to conventional protein aggregation detection dyes, such as Thioflavin T, the ProteoStat detection reagent can identify 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-micromolar range so that less than 1% protein aggregate is detectable in a protein solution.