Description :
Antibody and protein aggregation are important issues in the field of Biotherapeutics. A wide range of conditions and different stages of processing of biopharmaceuticals, such as, formulation, purification, storage, shipping and handling, heat, freeze thaw cycles, mechanical stress, chemical trea;ent etc. might cause aggregation of proteins, enzymes and antibody targets. The possibility of protein aggregates in eliciting immunogenicity is a major concern for biotherapeutics, which might compromise the safety and efficacy of the biologically derived drug products. Recombinant protein production and storage would highly benefit from a high throughput screening method that can screen a variety of formulation and storage conditions of a particular target proteintibody. Currently, different biophysical techniques such as Dynamic Light Scattering (DLS), Size-exclusion Chromatography with Multi-angle Light Scattering (SEC-MALS) can detect the presence of small amount of aggregates in a proteintibody preparation, but they are not amenable for high-throughput screening format. Antibody/Protein Aggregation assay kit is a platform to estimate the extent of aggregation within a proteintibody sample. This is a fast, high-throughput, plate-based fluorometric assay format and can detect as low as 0.5% antibody aggregate.