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Normal-temperature cell preserving fluid and cell preparation for injection

A technology of cell preparation and preservation solution, which is applied in the field of medical biology, can solve the problems of not being able to guarantee temperature stability, not suitable for low-temperature storage, and high price of cold chain, so as to achieve good maintenance of cell biological activity, activity and uniformity, The effect of saving economic cost

Inactive Publication Date: 2020-06-09
北京恒生佳合细胞科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the current conditions, professional cold chain delivery is expensive, especially when there is only one product in demand, the cost is even more expensive
However, the general low-temperature transportation method cannot guarantee the stability of the temperature during the transportation process, and the product may deteriorate due to excessive temperature changes along the way.
The clinical application suspension is generally stored at room temperature in a non-frozen manner, and it is not suitable for cryopreservation for cells that need to be used immediately without being treated
Whether it is in the human body or during the culture process, the cells have been growing at a temperature of about 37 degrees. Although the low temperature can slow down the metabolism of the cells to the greatest extent, it will also cause certain damage to the cells for a long time, especially in the process of repeated cooling and heating.

Method used

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  • Normal-temperature cell preserving fluid and cell preparation for injection
  • Normal-temperature cell preserving fluid and cell preparation for injection
  • Normal-temperature cell preserving fluid and cell preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] This example provides a method for preparing a cell preservation solution that can be transported at room temperature, specifically adding compound amino acid injection, human serum albumin injection, and vitamin C injection to normal saline (sodium chloride injection) in sequence In the process, mix thoroughly to complete the preparation.

[0038] In this embodiment, the reagents used and the manufacturer information are as follows:

[0039] Reagent name manufacturers Compound Amino Acid Injection Xinjiang Deyuan Biological Engineering Co., Ltd. Human Albumin Injection Chenxin Pharmaceutical Co., Ltd. Vitamin C Injection Henan Runhong Pharmaceutical Co., Ltd. Sodium Chloride Injection Shandong Qidu Pharmaceutical Co., Ltd. Compound Sodium Chloride Injection Shandong Qidu Pharmaceutical Co., Ltd.

[0040] Wherein, among the above-mentioned reagents, the specific components and contents of each reagent are as follows:

...

Embodiment 2

[0067] This example takes immune cells (CIK cells) as an example to verify cell survival rate and activity. The following cell operations are all completed in GMP pharmaceutical-grade laboratories. The specific steps are as follows:

[0068] 1) Take 30-50ml of peripheral blood from the patient, dilute it with PBS solution to an equal volume, perform density gradient centrifugation with Ficoll lymphatic separation medium (2000g, 22°C, 30min), and obtain PBMCS from peripheral blood mononuclear cells, wash them twice with normal saline, and then Suspend the cells with X-VIVO15 basal medium, adjust the cell density to 2×10 6 , placed at 37°C, 5% CO 2 cultured in a carbon dioxide incubator. On the 0th day of culture, add IFN-γ, 1000U / ml, 24h later, add anti-CD3 monoclonal antibody 100ng / ml, human recombinant IL-1α, 100U / ml, human recombinant IL-2, 1000U / ml. Afterwards, the culture medium was replaced every 2 to 3 days and IL-2 was added at 1000 U / ml. Harvest after 14 days.

[0...

Embodiment 3

[0079] This example takes umbilical cord mesenchymal stem cells (MSC cells) as an example to verify cell survival and activity. The following cell operations are all completed in GMP pharmaceutical-grade laboratories. The specific steps are as follows:

[0080] 1) Cut off a section of umbilical cord about 10cm long, rinse it repeatedly with normal saline, and cut it to 1-3mm 3 organization block. Use scissors to evenly spread the umbilical cord fragments on a 150mm petri dish, cover the lid, put it in a 37°C incubator upside down and adhere to the wall for 2 hours, then add 20ml of medium (add MSCBM-CD TM Single Quot TM LONZA Mesenchymal Stem Cell Medium with Growth Supplements). Place the Petri dish at 37 °C, 5% CO 2 cultured in an incubator. After culturing for 5-7 days, add 10ml of culture medium. On the 14th day, the cells crawling out were observed, all the tissue pieces were removed, and the cells were subcultured when the cells reached about 80% confluence. After t...

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Abstract

The invention relates to the technical field of medical biology, in particular to a normal-temperature cell preserving fluid and a cell preparation for injection. The normal-temperature cell preserving fluid comprises the following components in parts by volume: 1-10 parts of a human serum albumin injection, 0.5-5 parts of a vitamin C injection and 2-10 parts of a compound amino acid injection, with the balance being a sodium chloride injection, wherein the parts of the injections sum to 100 parts; and the sodium chloride injection is normal saline or a compound sodium chloride injection. According to the cell preparation for injection, immune cells or stem cells are suspended in a cell preserving fluid, namely the normal-temperature cell preserving fluid. The cell preserving fluid provided by the invention can well maintain the biological activity of cells at a normal temperature of 16-26 DEG C without changing the expression activity of the cells.

Description

technical field [0001] The invention relates to the field of medical biotechnology, in particular to a cell preservation solution and a cell preparation for injection. Background technique [0002] Cell therapy includes stem cell therapy and immune cell therapy for diseases such as tumors. Cell therapy, a method of injecting living cells into patients to treat certain diseases, has been hailed as "the third pillar of future medicine". In recent years, with the rapid development of life science and medicine, cell therapy technology has become one of the most eye-catching fields in recent years, coupled with the construction and development of cell banks in various places, and the resulting cell production and storage capabilities The expansion of the global cell therapy market has enhanced its capacity. [0003] The traditional method is to use physiological saline with added human serum albumin as the cell transport protection suspension. Due to its lack of nutrition and b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N1/02A61K9/08A61K47/42A61K47/22A61K47/18A61K47/02A61K35/17A61K35/51A61P35/00
CPCA01N1/0221A01N1/0226A61K9/0019A61K35/17A61K35/51A61K47/02A61K47/183A61K47/22A61K47/42A61P35/00
Inventor 林侯汎刘旭功迪力达尔·阿布都热合曼陈民才
Owner 北京恒生佳合细胞科技有限公司
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