Granted Patent B2

US 12,306,152 · App. 17/288,031 · Granted May 20, 2025

Inventors: Jonathan F. Hester (Hudson, WI); Eric J. Olson (Prior Lake, MN); Francis E. Porbeni (Woodbury, MN); Andrew W. Vail (Bayport, MN); Alexei M. Voloshin (Woodbury, MN)

Assignee: Solventum Intellectual Properties Company

G01N30/96C07K1/22G01N2030/889

Abstract

Claims (22)

1. A method for testing a chromatography device, said chromatography device having an inlet and an outlet and containing an ion exchange media, the method comprising:

(a) providing the ion exchange media having a first ion bound to the ion exchange sites of the ion exchange media;

(b) contacting the ion exchange media with a challenge solution, wherein the challenge solution comprises (i) a second ion, which binds to the ion exchange media and (ii) a non-binding species, which does not bind to the ion exchange media, wherein the second ion has a higher binding affinity to the ion exchange media than the first ion;

(c) monitoring an outlet fluid from the outlet of the chromatography device with at least one detector wherein both the second ion and the non-binding species are monitored;

(d) recording a breakthrough value of (i) the second ion and (ii) the non-binding species; and

(e) calculating a net breakthrough value using the breakthrough value of the non-binding species and the breakthrough value of the second ion.

2. The method of claim 1 comprising contacting the ion exchange media with a first solution comprising the first ion prior to contacting the ion exchange media with the challenge solution, optionally further comprising washing the chromatography device with a dilute solution after contacting the ion exchange media with the first solution, wherein the dilute solution contains neither the second ion nor the non-binding ion.

3. The method of claim 2 , wherein the dilute solution is water or a dilute salt solution.

4. The method of claim 3 , wherein the concentration of the first ion is lower in said dilute salt solution than in the first solution.

5. The method of claim 1 , wherein the first ion is acetate.

6. The method of claim 1 , wherein the second ion is chloride.

7. The method of claim 1 , wherein the non-binding species is potassium ion.

8. The method of claim 1 , wherein the first ion is lithium, and optionally wherein the non-binding species is a chloride ion.

9. The method of claim 8 , wherein the second ion is potassium.

10. The method of claim 1 , wherein the ion exchange media comprises at least one of a membrane, a functionalized nonwoven, a monolith, and a packed bed.

11. The method of claim 1 , wherein the at least one detector is selected from at least one of UV, conductivity, ion selective electrode, mass spectrometry, fluorescence, and luminescence.

12. The method of claim 1 , wherein the outlet fluid is monitored with at least two detectors and optionally, wherein at least one of the at least two detectors is an ion selective electrode.

13. The method of claim 1 , further comprising comparing the net breakthrough value to a known value of a reference integral device to determine integrity of the chromatography device.

14. The method of claim 1 , further comprising determining the adsorbent capacity from the net breakthrough value and comparing the adsorbent capacity with an expected adsorbent capacity.

15. The method of claim 1 , wherein the net breakthrough value is used to predict an expectant level of viral clearance.

16. The method of claim 1 , further comprising: passing a product-containing fluid through the chromatography device after monitoring the outlet fluid for the second ion and the non-binding species.

17. The method of claim 16 , further comprising performing a gas pressure-based integrity test after passing a product-containing fluid through the chromatography device, and optionally wherein the gas pressure-based integrity test is selected from ASTM F316-03 (2011) or ASTM D 6908-06(2017).

Assignments (2)

Continuity (2)

References Cited (34)