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It is produced on the B+A grade cGMP sterile canned production line, with components completely limited-- the number of protein types doesn’t exceed 20 and the total content is less than 1.5 mg/mL, all of which are artificially recombinant, without human-derived or animal-derived components. It has been filed with the US FDA DMF with the filing No. of 37873.
Primary cell separation and continuous subculturing to P20 can be achieved without changing the culture medium.
The products can improve cell adhesion and adaptability, hence suitable for large-scale production of cell products and 3D culture systems, and more suitable for constructing cell banks used to support clinical applications.
Specifications and Storage
Product name | Item No. | Specification | Purpose |
Basic MSC serum-free medium (GMP grade) | NC0106 | 500 mL/bottle | Addition of 5 mL of NC0106.S to 500 mL of NC0106 basic culture medium can be used for primary separation and subculture of mesenchymal stem cells |
MSC serum free medium additive (GMP grade) | NC0106.S | 5 mL/bottle |
This culture medium can be used for the primary cell isolation, seed - bank construction, and continuous sub - culture of human mesenchymal stem cells from various sources, while maintaining their multi - lineage differentiation potential, such as bone marrow (BM - hMSC) and umbilical cord (UCM - hMSC). No serum or serum substitutes are required when using this product.
This product has a well - defined chemical composition, with no added serum or serum substitutes (platelet lysate), and no components of animal or human origin. There is little batch - to - batch variation. All raw materials meet GMP standards, making it more suitable for clinical research purposes.
Main Components
Amino acids, vitamins, inorganic salts, recombinant human albumin, recombinant human transferrin, recombinant human insulin, trace elements, etc.
Product Design Principle
On the basis of basic culture media such as DMEM, MEM, and M199, various amino acids, vitamins, inorganic salts, human albumin, transferrin, insulin, and trace elements are added. It can not only isolate primary MSCs but also culture MSCs in the later stage. It can maintain the normal morphology and phenotype of cells. At the same time, by avoiding adding certain components in serum or serum substitutes that can promote the differentiation of stem cells, it can maintain the undifferentiated state of stem cells during the cell - passage process.
Product Performance Indicators
1. Time required for isolating primary cells from human umbilical cord
Take the explant method as an example:
Time when cell growth can be observed: 5 - 9 days.
Time when cells can be harvested: 12 - 15 days.
The umbilical cords referred to above are fresh umbilical cords. If they are edematous umbilical cords or umbilical cord tissues preserved by freezing, the time for the appearance of MSC cells is about 14 days, and the time when cells can be harvested is 21 days. There may also be cases where cells cannot be isolated.
2. Time required for cell sub - culture: 3 - 4 days (seeding density: 10,000 - 20,000 cells/cm²).
3. Cell phenotype
CD14, CD19, CD34, CD45 and HLA - DR are negative (< 2%), while CD44, CD73, CD90 and CD105 are positive (> 95%).
4. Cell morphology
The cells are spindle - shaped and grow in a fingerprint - like or swirling pattern.
5. Product specifications
Osmotic pressure: 280 - 350 mOsm/Kg; Endotoxin < 0.25 EU/mL; Sterility: Bacteria and fungi shall not be detected; Mycoplasma: shall not be detected; pH: 6.8 - 7.8; Appearance: Light yellow - yellow clear and transparent liquid; Volume: 500 mL/bottle.
Data of Continuous Subculturing
*The above data was obtained from GMP grade serum-free medium and stem cell mild digestive enzymes by Yocon Biology primary separation technique. Different umbilical cord samples and different separation techniques may lead to significant differences in results.
Specifications and Storage
Product name | Item No. | Specification | Purpose |
Basic MSC serum-free medium (GMP grade) | NC0106 | 500 mL/bottle | Addition of 5 mL of NC0106.S to 500 mL of NC0106 basic culture medium can be used for primary separation and subculture of mesenchymal stem cells |
MSC serum free medium additive (GMP grade) | NC0106.S | 5 mL/bottle |
This culture medium can be used for the primary cell isolation, seed - bank construction, and continuous sub - culture of human mesenchymal stem cells from various sources, while maintaining their multi - lineage differentiation potential, such as bone marrow (BM - hMSC) and umbilical cord (UCM - hMSC). No serum or serum substitutes are required when using this product.
This product has a well - defined chemical composition, with no added serum or serum substitutes (platelet lysate), and no components of animal or human origin. There is little batch - to - batch variation. All raw materials meet GMP standards, making it more suitable for clinical research purposes.
Main Components
Amino acids, vitamins, inorganic salts, recombinant human albumin, recombinant human transferrin, recombinant human insulin, trace elements, etc.
Product Design Principle
On the basis of basic culture media such as DMEM, MEM, and M199, various amino acids, vitamins, inorganic salts, human albumin, transferrin, insulin, and trace elements are added. It can not only isolate primary MSCs but also culture MSCs in the later stage. It can maintain the normal morphology and phenotype of cells. At the same time, by avoiding adding certain components in serum or serum substitutes that can promote the differentiation of stem cells, it can maintain the undifferentiated state of stem cells during the cell - passage process.
Product Performance Indicators
1. Time required for isolating primary cells from human umbilical cord
Take the explant method as an example:
Time when cell growth can be observed: 5 - 9 days.
Time when cells can be harvested: 12 - 15 days.
The umbilical cords referred to above are fresh umbilical cords. If they are edematous umbilical cords or umbilical cord tissues preserved by freezing, the time for the appearance of MSC cells is about 14 days, and the time when cells can be harvested is 21 days. There may also be cases where cells cannot be isolated.
2. Time required for cell sub - culture: 3 - 4 days (seeding density: 10,000 - 20,000 cells/cm²).
3. Cell phenotype
CD14, CD19, CD34, CD45 and HLA - DR are negative (< 2%), while CD44, CD73, CD90 and CD105 are positive (> 95%).
4. Cell morphology
The cells are spindle - shaped and grow in a fingerprint - like or swirling pattern.
5. Product specifications
Osmotic pressure: 280 - 350 mOsm/Kg; Endotoxin < 0.25 EU/mL; Sterility: Bacteria and fungi shall not be detected; Mycoplasma: shall not be detected; pH: 6.8 - 7.8; Appearance: Light yellow - yellow clear and transparent liquid; Volume: 500 mL/bottle.
Data of Continuous Subculturing
*The above data was obtained from GMP grade serum-free medium and stem cell mild digestive enzymes by Yocon Biology primary separation technique. Different umbilical cord samples and different separation techniques may lead to significant differences in results.
