 |
YOCON BIOTECH's GMP Serum-Free Mesenchymal Stem Cell Medium is a cutting-edge, chemically defined formulation designed for the optimal growth and maintenance of human Mesenchymal Stem Cells (MSCs). Manufactured on a state-of-the-art B+A grade cGMP sterile production line, this medium provides an ultra-pure, consistent, and safe environment for MSC expansion. It is completely free of human-derived, animal-derived, and undefined protein components, featuring only artificially recombinant proteins for unparalleled consistency. This premium medium supports everything from primary cell isolation to extensive subculturing (up to P20), making it ideal for clinical research, large-scale cell product manufacturing, and constructing robust cell banks.
Amino acids, vitamins, inorganic salts, recombinant human albumin, recombinant human transferrin, recombinant human insulin, trace elements, etc.
Category | Detail |
Product Grade | GMP Grade |
Production Line | B+A Grade cGMP Sterile Canned Production Line |
Protein Content | Types: ≤20 defined protein types Total Content: ≤1.5 mg/mL |
Components | All artificially recombinant, free of human/animal-derived ingredients. |
Regulatory Filing | US FDA DMF Filing No. 37873 |
Product Forms | Basic MSC Serum-Free Medium (GMP Grade): NC0106, 500 mL/bottle MSC Serum-Free Medium Additive (GMP Grade): NC0106.S, 5 mL/bottle (to be combined with basic medium) |
Performance Indicators | Primary Cell Isolation Time (Human Umbilical Cord, Explant Method) Observable Growth: 5-9 days (fresh umbilical cords) Harvest Time: 12-15 days (fresh umbilical cords) Note: Edematous or frozen umbilical cords may take longer (14 days for appearance, 21 days for harvest). Cell Subculture Time 3-4 days (seeding density: 10,000-20,000 cells/cm²) Cell Phenotype Negative: CD14, CD19, CD34, CD45, HLA-DR (＜2%) Positive: CD44, CD73, CD90, CD105 (＞ 95%) Cell Morphology: Spindle-shaped, growing in fingerprint-like or swirling patterns |
Quality Control Parameters | Osmotic Pressure: 280-350 mOsm/Kg Endotoxin: <$0.25 EU/mL Sterility: No bacteria or fungi detected Mycoplasma: No mycoplasma detected pH: 6.8-7.8 Appearance: Light yellow-yellow clear and transparent liquid Volume: 500 mL/bottle |
● Chemically Defined & Animal-Component Free: A highly controlled formulation with known chemical components, ensuring lot-to-lot consistency and eliminating risks associated with animal-derived xenogenic components.
● Ultra-Low Protein Content: Specifically designed with a limited number of protein types and low total protein content, reducing variability and potential for undesirable interactions.
● Optimized for MSCs: Tailored to support the primary isolation, robust proliferation, and continuous subculture of human MSCs from diverse sources (e.g., bone marrow, umbilical cord) while preserving their multi-lineage differentiation potential.
● GMP-Compliant Manufacturing: Produced in a B+A grade cGMP sterile environment with all raw materials meeting GMP standards, guaranteeing the highest quality and safety for clinical applications.
● FDA DMF Filed: Registered with the US FDA DMF (No. 37873), demonstrating adherence to stringent regulatory requirements for pharmaceutical ingredients.
● Exceptional Consistency & Reproducibility: The defined, serum-free, and animal-component-free nature, combined with cGMP manufacturing, significantly reduces batch-to-batch variability, leading to more reliable and reproducible experimental outcomes.
● Enhanced Safety for Clinical Use: Eliminates the risks associated with xenogenic components (e.g., prions, viruses, undefined growth factors) and human-derived components, making it an ideal choice for cell-based therapies and clinical research.
● Streamlined Workflow: Supports both primary isolation and continuous subculturing without the need for media changes, simplifying protocols and saving time.
● Robust Cell Growth: Proven to facilitate robust MSC expansion, achieving high cell yields while maintaining desired cell morphology and key phenotypic markers.
● Global Regulatory Acceptance: FDA DMF filing underscores its suitability for regulated applications worldwide, simplifying your path to clinical translation.
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.
*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.
YOCON BIOTECH's GMP Serum-Free Mesenchymal Stem Cell Medium is a cutting-edge, chemically defined formulation designed for the optimal growth and maintenance of human Mesenchymal Stem Cells (MSCs). Manufactured on a state-of-the-art B+A grade cGMP sterile production line, this medium provides an ultra-pure, consistent, and safe environment for MSC expansion. It is completely free of human-derived, animal-derived, and undefined protein components, featuring only artificially recombinant proteins for unparalleled consistency. This premium medium supports everything from primary cell isolation to extensive subculturing (up to P20), making it ideal for clinical research, large-scale cell product manufacturing, and constructing robust cell banks.
Amino acids, vitamins, inorganic salts, recombinant human albumin, recombinant human transferrin, recombinant human insulin, trace elements, etc.
Category | Detail |
Product Grade | GMP Grade |
Production Line | B+A Grade cGMP Sterile Canned Production Line |
Protein Content | Types: ≤20 defined protein types Total Content: ≤1.5 mg/mL |
Components | All artificially recombinant, free of human/animal-derived ingredients. |
Regulatory Filing | US FDA DMF Filing No. 37873 |
Product Forms | Basic MSC Serum-Free Medium (GMP Grade): NC0106, 500 mL/bottle MSC Serum-Free Medium Additive (GMP Grade): NC0106.S, 5 mL/bottle (to be combined with basic medium) |
Performance Indicators | Primary Cell Isolation Time (Human Umbilical Cord, Explant Method) Observable Growth: 5-9 days (fresh umbilical cords) Harvest Time: 12-15 days (fresh umbilical cords) Note: Edematous or frozen umbilical cords may take longer (14 days for appearance, 21 days for harvest). Cell Subculture Time 3-4 days (seeding density: 10,000-20,000 cells/cm²) Cell Phenotype Negative: CD14, CD19, CD34, CD45, HLA-DR (＜2%) Positive: CD44, CD73, CD90, CD105 (＞ 95%) Cell Morphology: Spindle-shaped, growing in fingerprint-like or swirling patterns |
Quality Control Parameters | Osmotic Pressure: 280-350 mOsm/Kg Endotoxin: <$0.25 EU/mL Sterility: No bacteria or fungi detected Mycoplasma: No mycoplasma detected pH: 6.8-7.8 Appearance: Light yellow-yellow clear and transparent liquid Volume: 500 mL/bottle |
● Chemically Defined & Animal-Component Free: A highly controlled formulation with known chemical components, ensuring lot-to-lot consistency and eliminating risks associated with animal-derived xenogenic components.
● Ultra-Low Protein Content: Specifically designed with a limited number of protein types and low total protein content, reducing variability and potential for undesirable interactions.
● Optimized for MSCs: Tailored to support the primary isolation, robust proliferation, and continuous subculture of human MSCs from diverse sources (e.g., bone marrow, umbilical cord) while preserving their multi-lineage differentiation potential.
● GMP-Compliant Manufacturing: Produced in a B+A grade cGMP sterile environment with all raw materials meeting GMP standards, guaranteeing the highest quality and safety for clinical applications.
● FDA DMF Filed: Registered with the US FDA DMF (No. 37873), demonstrating adherence to stringent regulatory requirements for pharmaceutical ingredients.
● Exceptional Consistency & Reproducibility: The defined, serum-free, and animal-component-free nature, combined with cGMP manufacturing, significantly reduces batch-to-batch variability, leading to more reliable and reproducible experimental outcomes.
● Enhanced Safety for Clinical Use: Eliminates the risks associated with xenogenic components (e.g., prions, viruses, undefined growth factors) and human-derived components, making it an ideal choice for cell-based therapies and clinical research.
● Streamlined Workflow: Supports both primary isolation and continuous subculturing without the need for media changes, simplifying protocols and saving time.
● Robust Cell Growth: Proven to facilitate robust MSC expansion, achieving high cell yields while maintaining desired cell morphology and key phenotypic markers.
● Global Regulatory Acceptance: FDA DMF filing underscores its suitability for regulated applications worldwide, simplifying your path to clinical translation.
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.
*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.
