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Mesenchymal Stem Cell (MSC) Serum-Free Medium Kit

FDA-Certified, GMP-Grade Medium for Reliable MSC Expansion

  • FDA 510(k) Registered | Animal-Free | High-Yield MSC Expansion

  • GMP Compliance for IND & Clinical Trials

Product Introduction

Serum-free medium kit for the primary isolation and expansion of mesenchymal stem cell (MSCs) derived from a variety of tissue sources. A 20 cm long normal umbilical cord can harvest2.4×10⁷cells in primary isolation, and maintain stable cell characteristics through continuous passages to P20.

A truly serum-free pure factor system, with no human-derived or animal-derived components, for which biocompatibility and toxicity experiments have been specifically conducted to guarantee the safety of the culture medium, and with more focuses on safety.

MSC_Serum_free_medium
Product nameItem No.SpecificationPurpose
Base of serum-free medium for mesenchymal stem cellsNC0103500 mL/vial

5 mL of NC0103.S added to 500 mL of NC0103 basic medium can be used for primary isolation of umbilical cord mesenchymal stem cells and construction of seed bank

 

5 mL of NC0105.S added to 500 mL of NC0103 basic medium can be used for numerous passages of umbilical cord mesenchymal stem cells

Supplement 1 of serum-free medium for mesenchymal stem cells (umbilical cord-isolation of primary cells and construction of seed bank)NC0103.S5 mL/vial
Supplement 2 of serum-free medium for mesenchymal stem cells (umbilical cord-passage of frozen cells and cells subject to numerous passages)NC0105.S5 mL/vial

Granted with US FDA Class II Medical Device Registration with No.510(K):K232543 and the company has conducted business cooperation with multiple drug application submitting enterprises at home and abroad.

msc sfm 510k FDA

Key Functionalities:

  • Broad Applicability:

    • Suitable for culturing MSCs derived from umbilical cord, bone marrow, and adipose tissue.
    • Optimized for both primary isolation and high-passage expansion, maintaining MSC characteristics up to P20 generations.

  • Enhanced Efficiency:

    • Supports large-scale MSC production, enabling high-yield cell harvesting from minimal starting material.
    • Ideal for clinical research, exosome production, and GMP-compliant manufacturing processes.

  • Simplified Workflow:

    • Designed for ease of use, reducing variability and improving consistency across batches.
    • Eliminates the need for serum supplementation, enabling a streamlined, serum-free process for cell therapy applications.

Safety and Quality Advantages:

  1. Defined Composition:

    • 100% animal-free and human-free, minimizing contamination risks and immunogenicity.
    • Manufactured under strict GMP guidelines, ensuring a high level of reproducibility and reliability.

  2. Regulatory Excellence:

    • Backed by FDA 510(k) certification (No. K232543), making it a trusted choice for clinical and regulatory environments.
    • Biocompatibility and toxicity-tested for optimal safety in therapeutic applications.

  3. IND and Clinical Trial Support:

    • Tailored for use in Investigational New Drug (IND) applications, offering a seamless pathway from research to clinical practice.
    • Proven compatibility with MSC-based therapies aimed at regenerative medicine and disease treatment.
Team of biochemistry scientists developing drugs agains new virus

Data of Continuous Subculturing

Version SelectionInoculum density (pcs/cm2)TimeConfluenceNumber of harvested cells (pcs)/150 dishesAmplification factorTotal harvested cells (pcs)Total amplification factor
Primary–Day 12-14–3.00E06–2.4E+07–
P1800072h80%~90%1.85E0715.4537E+0715
P21.58E0713.13486E+07203
P31.60E0713.316480E+072700
P41.38E0711.4874392E+0730997
P51.27E0710.56785576E+07327323
P6100001.62E0711.579089117E+073.79E6
P71.24E078.8480347790E+073.35E7
P81.53E0710.91876594392E+073.65E8
P91.08E077.686732244929E+072.81E9
P101.21E078.6258031951290E+072.42E10
P11120001.54E078.56496753503043E+072.07E11
P121.27E077.033492177126395E+071.46E12
P131.95E0710.8337820278278862E+071.58E13
P141.27E077.08267767570214344E+071.12E14
P159.77E065.431453977906263890E+076.06E14
P16150001.26E075.628171355833203050E+073.40E15
P171.16E075.1542082482540995700E+071.75E16
P181.22E075.42228087055372197000E+079.50E16
P191.03E074.561040076972497220000E+074.33E17
P209.18E064.084243514047788650000E+071.77E18

*The above data was obtained from 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.

Conditions for a good umbilical cord

No obvious edema or congestion in the umbilical cord.

Cord Huatong glue is thicker.

The umbilical cord is fresh, preferably ready to use, and should not be left for more than 48 hours.

The pregnant woman has no infectious diseases.

Transportation of Umbilical Cord

Umbilical Cord Delivery Fluid: During umbilical cord delivery, it should be transported at 4 degrees, stored in a liquid environment.

Short distance transportation (<6 hours) recommend to add DPBS or physiological saline plus dual antibody.

It is recommended to use complete culture medium and dual antibody for long-distance transportation (6h-24h).

If the umbilical cord is not processed after entering the laboratory, it should be immediately stored at 4 degrees Celsius.

Product Advantages

Numerous passages

The surface characteristics of mesenchymal stem cells remain stable from continuous passages to P20.

Safety-focused

This product has been tested for biocompatibility and toxicity in professional laboratories, showing excellent and more safety-focused performance.

Suitable for declaration of stem cell drugs

The product performance is witnessed during business cooperation with dozens of clinical study hospitals and pharmaceutical companies in China.

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