CN-224199360-U - Cutting sleeve device for preparing radionuclide marked cell preparation

CN224199360UCN 224199360 UCN224199360 UCN 224199360UCN-224199360-U

Abstract

The utility model discloses a cutting sleeve device for preparing a radionuclide labeling cell preparation, and relates to the technical field of radioactive biological medicines. The cutting sleeve device comprises a filtering component, a conveying component, a cleaning component, a waste liquid collecting bottle, a marking component, a cell preservation liquid component, a preparation collecting bottle, and a first three-way valve, a second three-way valve, a third three-way valve, a fourth three-way valve, a fifth three-way valve and a sixth three-way valve which are respectively and correspondingly arranged with the components. The clamping sleeve device can realize automatic preparation of the radionuclide-labeled cell preparation, and can also prevent products from being polluted while improving the preparation efficiency.

Inventors

LI SHIHONG
LIU QINGFENG
MIAO LIYAN
WANG YAN
ZHENG MENG
MOU HUIWEN

Assignees

苏州大学附属第一医院

Dates

Publication Date: 20260505
Application Date: 20250423

Claims (8)

1. A ferrule device for radionuclide labeling cell preparation, comprising: A filter assembly for filtering the separated cells and the solution; A delivery assembly comprising a cell preparation bottle and a gas delivery member, the gas delivery member in communication with the cell preparation bottle through a first three-way valve, the gas delivery member for delivering the cell preparation in the cell preparation bottle to the filter assembly; the cleaning component is connected with the cell preparation bottle and the filtering component through a second three-way valve and is used for conveying cell cleaning liquid into the filtering component; A waste collection bottle downstream of the filter assembly, the waste collection bottle being configured to communicate with the filter assembly through a third three-way valve, the waste collection bottle being configured to collect waste flowing from the filter assembly; The marking component is positioned between the third three-way valve and the waste liquid collecting bottle, is communicated with the third three-way valve through a fourth three-way valve and is used for conveying a radionuclide solution into the filtering component, and the radionuclide solution is used for carrying out radionuclide marking on the cells; A cell preservation fluid assembly downstream of the filter assembly, the cell preservation fluid assembly configured to communicate with the third three-way valve through a fifth three-way valve, the cell preservation fluid assembly configured to deliver a cell preparation medium to the filter assembly; A preparation collection bottle positioned between the second three-way valve and the filter assembly, the preparation collection bottle being configured to communicate with the second three-way valve and the filter assembly through a sixth three-way valve, the preparation collection bottle being configured to collect radionuclide-labeled cell preparation in the filter assembly, wherein, The second three-way valve is connected with the sixth three-way valve through a conveying pipeline, and the fourth three-way valve is connected with the waste liquid collecting bottle through the conveying pipeline.
2. The ferrule device of claim 1, wherein the filter assembly comprises: The filter pipe is internally provided with a cavity, and two ends of the filter pipe are respectively provided with an interface communicated with the conveying pipeline; And the cell sieve plate is positioned at the bottom of the cavity and is used for separating cells from the solution so as to keep the cells in the filter tube.
3. The ferrule device of claim 2 wherein the ferrule device comprises, The pore size of the cell sieve plate is any value from 0.6 μm to 10 μm.
4. A ferrule device according to claim 3, further comprising: The needle filter assembly comprises a first sterile needle filter and a plurality of second sterile needle filters, wherein the first sterile needle filter is positioned at one end of the first three-way valve, and each gas conveying piece, the cleaning assembly, the cell preservation liquid assembly and the marking assembly are correspondingly connected with one second sterile needle filter.
5. The ferrule device of claim 4, wherein the needle filter assembly further comprises: A third sterile spike filter connected to the formulation collection vial.
6. The ferrule device of claim 5 wherein the ferrule device comprises, The cleaning component is a sterile syringe filled with cell cleaning liquid.
7. The ferrule device of claim 5, wherein the cleaning assembly further comprises: A reagent bottle for holding the cell washing liquid; And the air conveying component is used for conveying air into the reagent bottle and conveying the cell cleaning liquid to the filtering component.
8. The ferrule device of claim 7, further comprising: And the controller component is used for controlling the opening and closing of the first three-way valve, the second three-way valve, the third three-way valve, the fourth three-way valve, the fifth three-way valve, the sixth three-way valve, the conveying component, the cleaning component, the marking component and the cell preservation liquid component.

Description

Cutting sleeve device for preparing radionuclide marked cell preparation Technical Field The utility model relates to the technical field of radioactive biological medicines, in particular to a cutting sleeve device for preparing a radionuclide marked cell preparation. Background Cell therapy is a major breakthrough in the medical field in recent years, and by utilizing human body self cells or modified cells to treat diseases, the cell therapy has strong therapeutic potential for treating a plurality of refractory diseases such as cancers, serious infections, autoimmune diseases, neurodegenerative diseases and the like. There are few therapeutic cell preparations commercially available internationally for clinical treatment of Crohn's disease, graft versus host disease, osteoarthritis, spinal cord injury, decompensated liver cirrhosis, hematological malignancies or other malignancies, and a number of cell therapies of various types in clinical trial stages. Various living cell products for therapy need to be developed in accordance with drug administration-related regulations. Measurement and evaluation of absorption, distribution, metabolism and excretion of drugs in vivo and pharmacokinetic properties are of great importance in drug development. However, it is difficult to evaluate these properties of therapeutic living cells by conventional pharmaceutical analysis techniques. While flow cytometry and Polymerase Chain Reaction (PCR) analysis methods can be used to evaluate the pharmacokinetic properties of transgenic cells, these techniques require the collection of ex vivo tissue samples, are difficult to perform, and are not suitable for evaluating other types of therapeutic cells. In the prior art, the cell radionuclide labeling and nuclear medicine imaging technology provides a non-invasive and high-sensitivity detection method with clinical application value for evaluating the distribution and pharmacokinetic properties of living medicines such as cells in vivo. For example, M-Oxine complexes formed by reacting metal radionuclides (M), such as 68Ga, 111In, and 89Zr, with 8-hydroxyquinoline (Oxine) can effectively label living cells under mild conditions, and In vitro experimental results indicate that the radioactive M-Oxine label of living cells is quite stable and does not transfer from the labeled living cells to other surrounding cells. Thus, the distribution and kinetic behavior of living cells in vivo after infusion can be accurately assessed by radioactively labeling the cells with M-Oxine and then performing nuclear medicine SPECT or PET imaging. However, the preparation of the existing radionuclide marked cells is basically manually operated by experimenters, the automation technology is lacked, the requirements of good production practice (GMP) are difficult to meet, the preparation process comprises a plurality of centrifugation steps, the cells are exposed in an open environment, the risk of pollution of the cells is high, and the popularization of the radiolabeled cell imaging method in clinical trials of new medicines of cell types is seriously affected. Disclosure of utility model The utility model aims to provide a cutting sleeve device for preparing a radionuclide-labeled cell preparation, which solves the technical problems that in the prior art, the GMP production condition and the product quality of the cell preparation are difficult to ensure when the radionuclide-labeled cell preparation is manually prepared. Another object of the utility model is to improve the ease of use of the ferrule arrangement. According to an object of the present utility model, there is provided a ferrule device for nuclide labeled cell preparation, comprising: A filter assembly for filtering the separated cells and the solution; A delivery assembly comprising a cell preparation bottle and a gas delivery member, the gas delivery member in communication with the cell preparation bottle through a first three-way valve, the gas delivery member for delivering the cell preparation of the cell preparation bottle to the filter assembly; the cleaning component is connected with the cell preparation bottle and the filtering component through a second three-way valve and is used for conveying cell cleaning liquid into the filtering component; A waste collection bottle downstream of the filter assembly, the waste collection bottle being configured to communicate with the filter assembly through a third three-way valve, the waste collection bottle being configured to collect waste from the filter assembly; The marking component is positioned between the third three-way valve and the waste liquid collecting bottle, is communicated with the third three-way valve through a fourth three-way valve and is used for conveying radionuclide marking solution for marking cells into the filtering component; A cell preservation fluid assembly downstream of the filter assembly, the cell preservation fluid assembly configured to