Method for purifying antibodies using PBS
AssigneesThe United States of America, as represented by the Secretary, Department of Health and Human Services, United Therapeutics Corporation
InventorsSamir H. Shaban, Mary P. Koleck, David A. Meh, Gerald M. Farquharson, Timothy O. Atolagbe, George Mitra
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Abstract
Disclosed here includes a method for purifying a biologic composition, comprising diafiltering the biologic composition into a composition comprising phosphate buffered saline (PBS) to obtain a purified composition. The method disclosed here can be particularly useful for removing one or more impurities from the biologic composition, such as bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (Bis-tris).
Claims10
A method for purifying a monoclonal antibody, comprising:
- (a) passing a first composition comprising the monoclonal antibody through an affinity chromatography column to obtain a second composition comprising the monoclonal antibody;
- (b) lowering the pH of the second composition to obtain a third composition;
- (c) washing the third composition with a solvent-detergent to obtained a fourth composition;
- (d) washing the fourth composition to remove the solvent-detergent to obtain a fifth composition;
- (e) passing the fifth composition through a cation exchange chromatography column to obtain a sixth composition comprising the monoclonal antibody;
- (f) subjecting the sixth composition to nano-filtration to obtain a seventh composition;
- (g) passing the seventh composition through a mixed mode chromatography column to obtain an eighth composition comprising the monoclonal antibody and Bis-tris;
- and
- (h) diafiltering the eighth composition into a composition comprising PBS to obtain a ninth composition comprising the monoclonal antibody but substantially free from Bis-tris,
- wherein the monoclonal antibody is ch14.18.
Dependencies are inferred from the claim text.