Characterization of Urate Oxidase Expressed in Escherichia Coli

The biological market is increasing day by day, so the regulatory bodies are becoming more stringent to maintain the quality of the product. To meet the highest quality standards, it is necessary to assess the quality of the product, in each and every step of the bio-therapeutic drug manufacturing. Originator molecule manufactures usually define their own standards, but where as a biosimilar producer should do head to head comparison with the standard molecule, in order to prove it as closely similar to the standard with respect to structure and function. In this paper, we compared urate oxidase produced in E. coli with the marketing Elitek which is expressed in yeast. We used various methods to determine its molecular weight, structural integrity, In-vitro bioassay and other methods to compare with the standard. Integrity by DSS cross linking is first of its kind for urate oxidase, expressed in E.coli.