Scientific Publications by FDA Staff

Protein Expr Purif 2017 Dec;140:28-35

An improved purification method for the lysosomal storage disease protein beta-glucuronidase produced in CHO cells.

Fratz-Berilla EJ, Ketcham SA, Parhiz H, Ashraf M, Madhavarao CN

Human beta-glucuronidase (GUS; EC 3.2.1.31) is a lysosomal enzyme that catalyzes the hydrolysis of beta-d-glucuronic acid residues from the non-reducing termini of glycosaminoglycans. Impairment in GUS function leads to the metabolic disorder mucopolysaccharidosis type VII, also known as Sly syndrome. We produced GUS from a CHO cell line grown in suspension in a 15 L perfused bioreactor and developed a three step purification procedure that yields approximately 99% pure enzyme with a recovery of more than 40%. The method can be completed in two days and has the potential to be integrated into a continuous manufacturing scheme.