Human peripheral lymphocyte separation medium (Endotoxin ≤ 0.03EU/ML)

Product Description

This product is a sterile, low endotoxin level, density gradient cell separation solution for the separation of single nucleated cells (mainly lymphocytes) from human peripheral blood.

Single nucleated cells in peripheral blood include lymphocytes and monocytes, etc., whose volume, morphology and density are different from those of other cells. Cells such as erythrocytes and granulocytes have a high density of about 1.090g/ml, while lymphocytes and monocytes have a density of 1.075~1.077g/ml, and platelets have a density of 1.030~1.035g/ml. This product formulates sodium pantothenate and hydroxyethyl starch into an isotonic cell separation solution with a density of 1.077g/ml in a certain proportion, and through density gradient centrifugation, it can make the cells distribute according to the corresponding density gradient in a shorter period of time, so as to separate the lymphocytes and monocytes from the blood cells.

The product is filtered and sterilized by 0.1μm membrane, the endotoxin content is ≤ 0.03EU/ML, and passed the sterility test.

Production process: This product is prepared by using Water-For-Injection (WFI), and the production procedure is strictly in accordance with the cGMP management regulations, and is completed in the clean room for the record of in vitro diagnostic reagents.

Product packaging form: 200mL/bottle

Product Advantage

• The product is easy to operate, with good separation effect and high purity of isolated lymphocytes.
• Ultra-low endotoxin level (endotoxin ≤ 0.03EU/mL), reducing exogenous endotoxin interference.
• Configuration of water for injection, production in accordance with GMP regulations, stable process, small batch variation.
• Raw materials are selected from self-produced or strictly tested and purified low endotoxin high-purity pharmaceutical grade raw materials.
• Strict quality testing procedures, much higher than the industry required indicators, superior product performance.
• Aseptic packaging bottles made of international materials, in line with GMP management regulations, excellent tightness and internal coating protection, greatly ensuring the stability of the product.

Performance

In order to identify the performance and effect of this product in separating lymphocytes, we have conducted a series of comparative experiments under the same conditions by using international brand products and this product as a control.

1. Human peripheral blood lymphocyte separation experiment

The operation steps of human peripheral blood lymphocyte separation test are shown in the instruction manual, and the results of the separation test are shown in Fig. 1, which are no different from those of imported brand products.

Figure 1.Comparison of human peripheral lymphocyte separation with international brand

2. Cell viability assay

We tested the survival rate of lymphocytes isolated from this product and the international brand products by Trypan Blue dye. As shown in Figure 2, the survival rate of lymphocytes isolated from this product was slightly higher than that of the international brand.

Figure 2.Comparison of cell viability

3. CD45 antibody labeling lymphocyte assay

We used CD3 antibody to label the lymphocytes isolated from this product and the international product to measure the content of T lymphocytes. As shown in Figure 3, the content of the isolated T lymphocytes is not significantly different from that of the international product.

Figure 3. CD3 antibody labels T-lymphocytes in lymphocytes for comparison with imported products.

Shipping and Storage 

• Storage：18-25 ℃ stored away from light, valid for 24 months. This product is susceptible to bacterial infection, and needs to be operated under aseptic conditions. It should be stored at 4℃ away from light after opening, and it is recommended to use it as soon as possible after opening. This separation medium is susceptible to crystallization when stored at 4℃ for a long period of time, affecting the separation effect.
• Shipment：Room temperature

Usage Statement

Research Use Only (RUO)