Aggregation is one of the most significant obstacles to the development of therapeutics proteins. During drug formulation, protein aggregation can impact product quality in terms of biological activity and immunogenicity.
Protein aggregation may occur at any stages of the manufacturing process including cell culture, purification, formulation, storage, shipping, and handling. The pharmaceutical industry requires improved methods to detect, monitor, and quantify factors governing aggregation during manufacturing. Unfortunately, monitoring and identification of these particles has been difficult and is limited to size-exclusion chromatography and native gel electrophoresis.
We provide simple & high throughput screening tools for rapid detection and characterization of Protein Aggregates by Flow Cytometry to overcome above problems during manufacturing of biotherapeutics.