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Cryopreserving solution for clinical-grade CAR-T cryopreservation and capable of being directly reinfused through intravenous infusion

A technology for cryogenic preservation and cryopreservation, which is applied in the fields of biotechnology applications and medicine, can solve the problems of unstable preservation effect, large batch differences, complex components, etc., and achieves the effects of long shelf life, convenient operation and simple preparation.

Inactive Publication Date: 2018-09-21
WUHAN BIO RAID BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This kind of ready-to-use cryopreservation solution needs to be prepared and used immediately, the storage period is short, the batch difference is large, and the storage effect is unstable
And the composition is complex, especially the patient's own serum may contain various uncertain harmful substances
The most important point is the conventional cryopreservation solution, which cannot be directly injected intravenously for reinfusion

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A cryopreservation solution for CAR-T clinical grade cryopreservation and direct intravenous injection reinfusion, comprising the following components: CryoSure-DMSO dimethyl sulfoxide (USP clinical grade) 5.5% (v / v); glycerol Fructose Sodium Chloride Injection 2% (v / v); Invert Sugar Electrolyte Injection 37% (v / v); Dextran 40 Glucose Injection 6% (v / v); Hydroxyethyl Starch 130 / 0.4 Electrolyte Injection 10% (v / v); vitamin C injection 1.2% (v / v); human albumin injection 35% (v / v); 0.9% sodium chloride injection 3.3% (v / v). Purchase the above-mentioned components, mix them in proportion in a medical safety cabinet, freeze and store CAR-T cells for 48 hours according to this formula, and then thaw the cells to obtain a recovery survival rate of more than 62%.

Embodiment 2

[0025] A cryopreservation solution for CAR-T clinical grade cryopreservation and direct intravenous injection reinfusion, including the following components: CryoSure-DMSO dimethyl sulfoxide (USP clinical grade) 7.5% (v / v); glycerol Fructose Sodium Chloride Injection 0% (v / v); Invert Sugar Electrolyte Injection 37% (v / v); Dextran 40 Glucose Injection 6% (v / v), Hydroxyethyl Starch 130 / 0.4 Electrolyte Injection 10% (v / v); vitamin C injection 1.2% (v / v); human albumin injection 35% (v / v); 0.9% sodium chloride injection 3.3% (v / v). Purchase the above-mentioned components, mix them in proportion in a medical safety cabinet, freeze and store CAR-T cells for 48 hours according to this formula, and then thaw the cells to obtain a recovery survival rate of more than 80%.

Embodiment 3

[0027] A cryopreservation solution for CAR-T clinical grade cryopreservation and direct intravenous injection reinfusion, including the following components: CryoSure-DMSO dimethyl sulfoxide (USP clinical grade) 7.5% (v / v); glycerol Fructose Sodium Chloride Injection 0% (v / v); Invert Sugar Electrolyte Injection 37% (v / v); Dextran 40 Glucose Injection 6% (v / v); Hydroxyethyl Starch 130 / 0.4 Electrolyte Injection 10% (v / v); vitamin C injection 1.4% (v / v); human albumin injection 35% (v / v); 0.9% sodium chloride injection 3.1% (v / v). Purchase the above-mentioned components, mix them in proportion in a medical safety cabinet, freeze and store CAR-T cells according to this formula for 48 hours, and then thaw the cells to obtain a recovery survival rate of more than 71%.

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PUM

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Abstract

The invention discloses a cryopreserving solution for clinical-grade CAR-T cryopreservation and capable of being directly reinfused through intravenous infusion. The cryopreserving solution comprisesthe following raw materials: dimethyl sulfoxide, a glycerol fructose sodium chloride injection, an invert sugar electrolyte injection, a dextran 40 glucose injection, a hydroxyethyl starch 130 / 0.4 electrolyte injection, a vitamin C injection, a human serum albumin injection and a 0.9 % sodium chloride injection; the cryopreserving solution has the pH value of 6.8-7.0. When a formula for the clinical-grade CAR-T cryopreservation and capable of being directly reinfused through the intravenous infusion is used for cryopreserving CAR-T cells, the thawed cells and the thawed cryopreserving solutiondo not need centrifugation, resuspension, fluid exchange and other processes and can be directly reinfused through the intravenous infusion, so that the loss of cell varieties due to pollution in-vitro repeated proliferation of the CAR-T cells, or changes of cell morphologies and cell functions are effectively avoided, medical equipment can be also significantly simplified and the workload of medical workers can be reduced.

Description

technical field [0001] The invention belongs to the fields of biotechnology application and medical technology, and in particular relates to a cryopreservation solution for clinical-grade cryopreservation of CAR-T and capable of direct intravenous injection and reinfusion. technical background [0002] Cytotoxic T lymphocytes (CTLs) are the main anti-tumor effector lymphocytes in the body, but the killing activity of CTLs is limited by MHC-I protein complexes, which greatly reduces the therapeutic effect of CTLs. Therefore, in the late 1980s, researchers such as Gross proposed the concept of CAR-T cell adoptive immunotherapy. CAR cells are artificial receptors that mimic the function of T cell receptors. They are sequentially connected by the antigen recognition domain SCFV and a series of signaling domains of T cells. This type of T cells bypasses the major histocompatibility complex of conventional cellular immunity. (MHC) restriction, and then directly transmit the recog...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N1/02A61K35/17A61K9/08A61K47/20A61K47/26A61K47/36A61K47/22A61K47/42A61K47/02
CPCA01N1/021A01N1/0226A61K9/0019A61K9/08A61K35/17A61K47/02A61K47/20A61K47/22A61K47/26A61K47/36A61K47/42
Inventor 张同存唐取来
Owner WUHAN BIO RAID BIOTECH CO LTD
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