Disclosed herein are methods preparing a purified, carrier-free 68Ga solution. Tire present disclosure also provides systems for preparing a purified, carrier-free 68Ga solution. The present disclosure also provides compositions comprising the purified, carrier-free 68Ga solutions disclosed herein. Also provided are methods of administering compositions of the present disclosure to a patient in need thereof, for example, for imaging a disease or disorder, such as cancer.

Gallium-68 generators that are capable of producing gallium-68 from a germanium-68 source material are disclosed. The source material may be a matrix material (e.g., zeolite) in which germanium-68 is isomorphously substituted for central atoms in tetrahedra within the matrix material. Methods for forming gallium-68 generators are also disclosed.

A .sup.68Ge/.sup.68Ga generator for a continuous production of a .sup.68Ga daughter nuclide, wherein the .sup.68Ge parent nuclide thereof is specifically adsorbed to an inorganic support material and wherein said .sup.68Ge parent nuclide continuously decays to .sup.68Ga by electron capture at a half-life of 270.82 d, wherein the inorganic support material is at least one oxide of a metal being selected from the group consisting of: Vanadium, Niobium and Tantalum. The use of at least one oxide of a metal being selected from the group consisting of: Vanadium, Niobium and Tantalum as an inorganic support material for the manufacture of a .sup.68Ge/.sup.68Ga generator for pharmaceutical purposes. With the inorganic support material of the present invention, it is possible to load .sup.68Ge/.sup.68Ga generators with up to 8000 MBq of .sup.68Ge (corresponding to 80 g Germanium).

Processes for producing germanium-68 from a gallium target body are disclosed. In some embodiments, germanium-68 and gallium are precipitated to remove metal impurities. Germanium-68 and gallium are re-dissolved and loaded onto an ion exchange column to separate germanium-68 from gallium.

The present invention is directed to a system, apparatus, and method for producing gallium radioisotopes on particle accelerators using solid targets and a Ga-68 composition produced by this method. The solid target assembly apparatus has a metal disc and a zinc portion on the top of the disc. The apparatus is made by preparing a quantity of zinc, depositing it onto a metal disc, melting the zinc, and allowing it to cool and solidify. The disc surface may be prepared before applying zinc to it in order to facilitate bonding between the substrate and the zinc. Ga-68 is produced by placing the apparatus in a cyclotron target irradiation station, irradiating it, separating it from the irradiated Zn, and collecting and storing the separated Ga-68. The Ga-68 composition has the following quotient of activity quantity ratios: Ga-67/Ga-68 less than 1, and Ga-67/Ga-68 less than 1.

The present disclosure relates to a process for purifying and concentrating .sup.68Ga isotope produced by irradiation with an accelerated particle beam of a .sup.68Zn target in solution. The process according to the present disclosure allows for the production of pure and concentrated .sup.68Ga isotope in hydrochloric acid solution. The present disclosure also relates to a disposable cassette for performing the steps of purification and concentration of the process.

Target assembly includes a target body having a production chamber and a beam passage. The target body includes first and second grid sections that are disposed in the beam passage. Each of the first and second grid sections has front and back sides. The back side of the first grid section and the front side of the second grid section abut each other with an interface therebetween. The back side of the second grid section faces the production chamber. The target assembly also includes a foil positioned between the first and second grid sections. Each of the first and second grid sections has interior walls that define grid channels through the first and second grid sections. The particle beam is configured to pass through the grid channels toward the production chamber. The interior walls of the first and second grid sections engage opposite sides of the foil.

Methods of producing and isolating .sup.68Ga, .sup.89Zr, .sup.64Cu, .sup.63Zn, .sup.86Y, .sup.61Cu, .sup.99mTc, .sup.45Ti, .sup.13N, .sup.52Mn, or .sup.44Sc and solution targets for use in the methods are disclosed. The methods of producing .sup.68Ga, .sup.89Zr, .sup.64Cu, .sup.63Zn, .sup.86Y, .sup.61Cu, .sup.99mTc, .sup.45Ti, .sup.13N, .sup.52Mn, or .sup.44Sc include irradiating a closed target system with a proton beam. The system can include a solution target. The methods of producing isolated .sup.68Ga, .sup.89Zr, .sup.64Cu, .sup.63Zn, .sup.86Y, .sup.61Cu, .sup.99mTc, .sup.45Ti, .sup.52Mn, or .sup.44Sc further include isolating .sup.68Ga, .sup.89Zr, .sup.64Cu, .sup.63Zn, .sup.86Y, .sup.61Cu, .sup.99mTc, .sup.45Ti, .sup.52Mn, or .sup.44Sc by ion exchange chromatography. An example target includes a target body including a target cavity for receiving the target material; a housing defining a passageway for directing a particle beam at the target cavity; a target window for covering an opening of the target cavity; and a coolant gas flow path disposed in the passageway upstream of the target window.

Chromatography columns for the purification of eluates from .sup.68Ge/.sup.68Ga generators comprising silica as stationary phase and purification processes that use said columns are described.

The present disclosure relates processes and systems for producing and/or purifying .sup.68Ga from an irradiated substrate of .sup.68Zn. In some embodiments, the process rely on the use two cation-exchange chromatography columns to separate .sup.68Ga from .sup.68Zn and other radionuclides and metallic impurities. The process achieves a high overall yield of .sup.68Ga and a high effective molar activity while being implementable in a time compatible with the short half-life of .sup.68Ga. In additional embodiments, the process is implemented by an automated system.