(1,3)-β-D-glucans, polysaccharides derived from the cell walls of bacteria, are known to cause a false positive in endotoxin assays and illicit adverse immune responses. These molecules are polysaccharides of D-glucose monomers linked by β-glycosidic bonds. β-glucans can be introduced into product media from multiple sources: 1) Host cell impurities from a yeast cell line; 2) Yeastolate components which may be added to the media; 3) Cellulose leachables from depth filters; 4) Additives which contain contaminants such as sucrose. Previous studies have demonstrated that nylon 6,6 membranes have the potential to remove (1,3)-β-D-glucans from buffer media to acceptable levels, though the mechanism of removal is not well understood. In the current study, an inverse relationship between solution pH and load capacity of both β-glucans on nylon 6,6 membranes has been observed in breakthrough studies.  To determine the potential interaction mechanism between nylon 6,6 and β-glucans, nylon 6,6 membrane filters were saturated with (1,3)-β-D-glucans, then stripped with various solutions.

Mechanism study on the removal of β-Glucans by nylon membrane filters in biopharmaceutical manufacturing process

ACS Fall 2021

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