US 11,655,461 B2
Antigen purification
Steven D. Hume, Owensboro, KY (US); Leigh Burden, Owensboro, KY (US); Joshua Morton, Evansville, IN (US); Greg Pogue, Austin, TX (US); Barry Bratcher, Owensboro, KY (US); Hugh A. Haydon, Louisville, KY (US); Carrie A. Simpson, Evansville, IN (US); Nick Partain, Owensboro, KY (US); John W. Shepherd, Owensboro, KY (US); and Kelsi Swope, Maceo, KY (US)
Assigned to KBIO HOLDINGS LIMITED, London (GB)
Filed by KBIO HOLDINGS LIMITED, London (GB)
Filed on Oct. 5, 2020, as Appl. No. 17/63,022.
Application 17/063,022 is a continuation of application No. 16/437,770, filed on Jun. 11, 2019, granted, now 10,822,591.
Claims priority of provisional application 62/683,865, filed on Jun. 12, 2018.
Prior Publication US 2021/0017502 A1, Jan. 21, 2021
Int. Cl. A61K 39/00 (2006.01); B01D 15/34 (2006.01); B01D 15/36 (2006.01); B01D 15/38 (2006.01); C07K 1/16 (2006.01); C07K 1/18 (2006.01); C07K 1/22 (2006.01); C12N 7/00 (2006.01); A61K 39/145 (2006.01); A61K 47/69 (2017.01); A61K 38/36 (2006.01)
CPC C12N 7/00 (2013.01) [A61K 38/36 (2013.01); A61K 39/0001 (2013.01); A61K 39/145 (2013.01); A61K 47/6901 (2017.08); B01D 15/34 (2013.01); B01D 15/361 (2013.01); B01D 15/3809 (2013.01); B01D 15/3847 (2013.01); C07K 1/16 (2013.01); C07K 1/18 (2013.01); C07K 1/22 (2013.01); A61K 2039/5254 (2013.01); C12N 2770/00051 (2013.01); C12N 2770/00061 (2013.01); C12N 2770/40051 (2013.01); C12N 2770/40061 (2013.01)] 11 Claims
 
1. A method for purifying at least one antigen harvested from a source organism, comprising:
extracting cellular debris from the at least one antigen by adding an extraction buffer to an extract at a ratio of the extraction buffer and the extract expressed as extraction buffer:extract by wt;
after the extracting step, concentrating the at least one antigen by passing the at least one antigen through a tangential flow filtration apparatus; and
performing separations comprising sub-steps of separating host cell contaminants from the at least one antigen, subjecting the at least one antigen to affinity chromatography to elute the at least one antigen, and after the separating host cell contaminants and affinity chromatograph sub-steps, subjecting the at least one antigen to multi-modal chromatography to separate residual impurities from the at least one antigen.