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Updated: Feb 26, 2026
Evaluation of the Storage Stability of Extracellular Vesicles
Published on: May 22, 2019
An improved purification method for the lysosomal storage disease protein β-glucuronidase produced in CHO cells
Erica J Fratz-Berilla1, Stephanie A Ketcham1, Hamideh Parhiz1
1Division of Product Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Abstract:
Human β-glucuronidase (GUS; EC 3.2.1.31) is a lysosomal enzyme that catalyzes the hydrolysis of β-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 ∼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.
