US 12,305,198 B2
Virus purification and formulation process
John J. Vicalvi, Jr., Marlborough, MA (US); Edward G. Hayman, Hanover, NH (US); and Joseph Makowiecki, Oxford, MA (US)
Assigned to GLOBAL LIFE SCIENCES SOLUTIONS USA LLC, Marlborough, MA (US)
Filed by GLOBAL LIFE SCIENCES SOLUTIONS USA LLC, Marlborough, MA (US)
Filed on Dec. 20, 2022, as Appl. No. 18/085,110.
Application 18/085,110 is a continuation of application No. 16/229,836, filed on Dec. 21, 2018, abandoned.
Application 16/229,836 is a continuation of application No. 15/163,288, filed on May 24, 2016, granted, now 10,196,615.
Application 15/163,288 is a continuation of application No. 14/423,394, abandoned, previously published as PCT/US2013/055302, filed on Aug. 16, 2013.
Claims priority of provisional application 61/692,956, filed on Aug. 24, 2012.
Prior Publication US 2023/0122337 A1, Apr. 20, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. C12N 7/00 (2006.01)
CPC C12N 7/00 (2013.01) [C12N 2770/24151 (2013.01); C12N 2770/24163 (2013.01)] 8 Claims
 
1. A process for making a virus product comprising:
a. obtaining a composition suitable for purification from a virus-infected host cell culture;
b. clarifying the composition obtained in step “a” by removing cells and cell debris from said composition by depth filtration;
c. subjecting the filtrate in step “b” to endonuclease digestion and 0.2 micron filtration sufficient to fragment host cell DNA followed by filtration;
d. purifying the filtrate obtained in step “c” via a cross-linked agarose matrix with a dextran sulfate functional group chromatography resin and a cross-linked agarose matrix with an octylamine ligand chromatography resin having a shell that excludes molecules with a molecular mass greater than approximately 700 kDa from passing through pores of the shell;
e. stabilizing and inactivating the product obtained in step “d” with an inactivating amount of β-PL;
f. after inactivating the product in step “e,” adjusting the temperature of the product from a lower temperature to about 25-30° C.;
g. filtering the product obtained in step “f”; and,
h. formulating the product obtained in step “g” bound to alum.