Purification process for the preparation of non-carrier added copper-64

Patent metadata

Field	Value
Publication number	US-2026074084-A1
Application number	US-202519396014-A
Country	US
Kind code	A1
Filing date	Nov 20, 2025
Priority date	Sep 3, 2020
Publication date	Mar 12, 2026
Grant date	—

Abstract

Compositions comprising high levels of high specific activity copper-64, and process for preparing said compositions. The compositions comprise from about 2 Ci to about 15 Ci of copper-64 and have specific activities up to about 3800 mCi copper-64 per microgram of copper. The processes for preparing said compositions comprise bombarding a nickel-64 target with a low energy, high current proton beam, and purifying the copper-64 from other metals by a process comprising ion exchange chromatography or a process comprising a combination of extraction chromatography and ion exchange chromatography.

First claim

What is claimed is:

1 . A process for preparing copper-64 ( 64 Cu) from nickel-64 ( 64 Ni), the process comprising:
(a) bombarding a cyclotron target comprising 64 Ni with a proton beam to generate a bombarded target; (b) stripping the bombarded target with a volume of hydrochloric acid (HCl) having a molarity of about 6 M to about 12.1 M to form a strip solution comprising 64 Ni and 64 Cu; and (c) purifying the 64 Cu from the strip solution by:
(i) passing the strip solution through a column comprising an ion exchange resin such that 64 Cu binds to the ion exchange resin and 64 Ni passes through the column as a flow-through;
(ii) rinsing the column with a volume of HCl having a molarity of about 3 M to about 6 M; and
(iii) adding a volume of HCl having a molarity of about 0.5 M to about 3 M to the column to elute the 64 Cu from the ion exchange resin and collecting an eluate comprising 64 Cu.

2 . The process of claim 1 , wherein the cyclotron target comprises about 50 mg of 64 Ni plated in an area of about 4.0 cm 2 .

3 . The process of claim 1 , wherein the proton beam has an energy of about 10 MeV to about 14 MeV and a current of about 100 μA to about 250 μA.

4 . The process of claim 1 , wherein the proton beam has an energy of about 12 MeV and a current up to about 225 μA.

5 . The process of claim 1 , wherein the bombarding proceeds for about 1 h to about 6 h.

6 . The process of claim 1 , wherein after the bombarding, the bombarded target comprises from about 2 Ci to about 82 Ci of 64 Cu at the end of bombardment (EOB).

7 . The process of claim 1 , wherein after about 2 h to about 4 h of bombarding, the bombarded target comprises from about 2 Ci to about 5 Ci of 64 Cu at EOB.

8 . The process of claim 1 , wherein after about 2 h to about 4 h of bombarding, the bombarded target comprises from about 2 Ci to about 15 Ci of 64 Cu at EOB.

9 . The process of claim 1 , wherein the stripping of the bombarded target is conducted at a temperature of about 65° C. to about 100° C.

10 . The process of claim 1 , wherein the stripping comprises contacting the bombarded target three times with an aliquot of 9 M HCl for about 3-5 minutes each time, and collecting the aliquots as the strip solution.

11 . The process of claim 1 , wherein the bombarded target is rinsed with an additional aliquot of 9 M HCl, which is then added to the strip solution.

12 . The process of claim 1 , wherein the ion exchange resin is a strong anion exchange resin comprising trimethylbenzyl ammonium chloride groups.

13 . The process of claim 1 , wherein the flow-through from passing the strip solution through the column is collected as a 64 Ni recovery fraction.

14 . The process of claim 13 , wherein after passing the strip solution through the column, a further volume of 9 M HCl is added to the column and its flow-through is combined with the 64 Ni recovery fraction.

15 . The process of claim 13 , wherein an average of about 82% of the target 64 Ni is recovered in the 64 Ni recovery fraction.

16 . The process of claim 1 , wherein the rinsing comprises adding 4 M HCl to the column to elute cobalt, which is collected as a waste fraction.

17 . The process of claim 1 , wherein the 64 Cu is eluted from the column with 2 M HCl.

18 . The process of claim 1 , wherein an average of about 80% of the 64 Cu present in the strip solution is recovered in the eluate comprising 64 Cu.

19 . The process of claim 1 , wherein the eluate comprising 64 Cu is evaporated to dryness and reconstituted in 0.05 M HCl, thereby forming a final product comprising 64 CU.

20 . The process of claim 19 , wherein the final product comprising 64 Cu comprises from about 2 Ci to about 15 Ci of 64 Cu.

21 . The process of claim 19 , wherein the final product comprising 64 Cu has a specific activity up to about 3800 mCi 64 Cu/μg Cu.

22 . The process of claim 19 , wherein the final product comprising 64 Cu has a total content of trace metals of less than about 5 ppm, the trace metals being cobalt, copper, gold, iron, lead, mercury, nickel, and zinc.

23 . A process for preparing copper-64 ( 64 Cu) from nickel-64 ( 64 Ni), the process comprising:
(a) bombarding a cyclotron target comprising 64 Ni with a proton beam to generate a bombarded target; (b) stripping the bombarded target with a volume of HCl having a molarity of about 6 M to about 12.1 M to form a strip solution comprising 64 Ni, 64 Cu, 61 Co, and one or more trace metals; and (c) purifying the 64 Cu from the strip solution by chromatography, wherein the chromatography comprises
(i) passing the strip solution through a first column comprising an extraction resin connected in series to a second column comprising an ion exchange resin, such that the one or more trace metals binds to the extraction resin in the first column, 64 Cu and 61 Co bind to the ion exchange resin in the second column, and 64 Ni passes through both columns as a first flow-through fraction;
(ii) rinsing the first and second columns with a volume of HCl having a molarity of about 6 M to about 12.1 M to remove residual 64 Ni as a second flow-through fraction;
(iii) rinsing the second column with a volume of HCl having a molarity of about 3 M to about 6 M to elute 61 Co as a first waste fraction;
(iv) rinsing the second column with a volume of NaCl having a molarity of about 3 M to 6 M in HCl having a molarity of about 0.01 M to about 3 M to elute residual 61 Co as a second waste fraction or rinsing the second column with an additional volume of HCl having a molarity of about 3 M to about 6 M to elute 61 Co as a second waste fraction; and
(v) adding a volume of HCl having a molarity of about 0.01 M to about 3 M to the second column to elute the 64 Cu as a product fraction comprising 64 CU.

24 . The process of claim 23 , wherein the cyclotron target at (a) comprises about 750 mg of 64 Ni plated in an area of about 23.0 cm 2 .

25 . The process of claim 23 , wherein the proton beam at (a) has an energy of about 10 MeV to about 15 MeV and a current of about 350 μA to about 408 μA.

26 . The process of claim 23 , wherein the proton beam at (a) has an energy of about 13 MeV and a current of about 350 μA to about 408 μA.

27 . The process of claim 23 , wherein the stripping at (b) comprises contacting the bombarded target with 9 M HCl, and the stripping at (b) is conducted at a temperature of about 65° C. to about 100° C.

28 . The process of claim 23 , wherein the extraction resin in the first column at (c)(i) comprises tributylphosphate as a functional group, and the ion exchange resin in the second column at (c)(i) comprises a tertiary amine as a functional group.

29 . The process of claim 23 , wherein the rinsing at (c)(iii) comprises 4 M HCl, and the rising at (c)(iv) comprises 5 M NaCl in 0.05 M HCl or additional 4 M HCl.

30 . A process for preparing copper-64 ( 64 Cu) from nickel-64 ( 64 Ni), the process comprising:
(a) bombarding a cyclotron target comprising 64 Ni with a proton beam to generate a bombarded target; (b) stripping the bombarded target with a volume of acid to form a strip solution comprising 64 Ni and 64 Cu; and (c) purifying the 64 Cu from the strip solution to yield a 64 Cu product, wherein the product has a specific activity up to about 380

Assignees

• Curium Us Llc

Inventors

• Pipes David
• Radford Lauren
• Uhland William
• Regna Brian
• Brunkhorst Craig
• Loveless Shaun

Classifications

• G21G4/08

  specially adapted for medical application (radiation therapy using radioactive sources A61N5/10) · CPC title

• A61K51/0482

  chelates from cyclic ligands, e.g. DOTA · CPC title

• G21G2001/0094

  Other isotopes not provided for in the groups listed above · CPC title

• C01G3/003

  Preparation involving a liquid-liquid extraction, an adsorption or an ion-exchange · CPC title

• G21G1/10

  by bombardment with electrically charged particles (irradiation devices G21K5/00) · CPC title