Regenerative Exosome Science · GMP Manufactured

What Are Exosomes & GMP Standards

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About Exosomes

What are exosomes?

Exosomes are tiny vesicles secreted by cells outside the body, with a diameter of approximately 30–150 nm. They act as “miniature couriers” between cells, encapsulating vital information such as proteins, lipids, and nucleic acids (e.g., RNA/DNA), specifically responsible for transmitting instructions between cells to regulate bodily functions and promote tissue repair.

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Information Delivery

Encapsulates active ingredients such as proteins and RNA, delivering them targeted to specific cells to regulate bodily functions.

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High Efficiency & Safety

Extremely small and easily absorbed, lacking a cell nucleus, thus minimizing the risk of immune rejection.

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Core Efficacy

Powerful anti-inflammatory, tissue-repair and collagen-regeneration-promoting capabilities.

Main Applications

Widely used in medical aesthetics for anti-aging, hair-loss treatment, and clinical targeted drug development.

Production Standards

Exosome production standards (GMP laboratory)

MYS-Exo’s products undergo nine core manufacturing processes and 533 quality-control checks across the entire process to produce GMP-certified, pharmaceutical-grade exosome raw materials. These materials suit a wide range of regenerative-medicine research scenarios and offer higher safety, stronger activity, broader cell targeting and better functionality.

Our laboratory exosomes differ from the four common types of stem-cell exosomes — cell-culture-medium type, stem-cell-supernatant type, laboratory grade and stem-cell by-product type. We rigorously test exosomes for basic characterization, safety, composition and purity. All our stem-cell exosome raw materials are produced in strict accordance with pharmaceutical standards and are GMP-grade, and the ingredients of every product are fully traceable.

9Core manufacturing processes
533Whole-process QC checks
GMPPharmaceutical-grade standard
100%Traceable ingredients

Our GMP-laboratory production process

Injectable-Grade Materials01

Injectable-Grade Materials

All raw, auxiliary and consumable materials are injectable grade, managed to cGMP pharmaceutical standards — fully traceable.

High-Quality Seed Stem Cells02

High-Quality Seed Stem Cells

Umbilical-cord MSCs pass 26-item QC: endotoxin, virus, phenotype, anti-inflammatory and regenerative factor secretion.

3D Hyper-Active Culture03

3D Hyper-Active Culture

3D culture yields 3–5× more exosomes than 2D, with daily monitoring of viability, metabolism and secretion.

dTFCC® Ultra-Purification04

dTFCC® Ultra-Purification

Patented stable, scalable tangential ultra-filtration for high-purity, large-scale exosome extraction.

3.0 Protection Formula05

3.0 Protection Formula

Upgraded patented preservation formula keeps lyophilized exosomes optimally active at 2–8°C.

Automated Aseptic Filling06

Automated Aseptic Filling

Patented lyophilization and a fully automated aseptic filling line for efficient, sterile large-scale production.

30-Item Quality Control07

30-Item Quality Control

A 7-dimension quality system with 30+ tests per batch — identity, content, purity, bioactivity, impurity, pharmacopoeia and omics.

One-Vote-Veto Release08

One-Vote-Veto Release

Every batch is activity-tested; a single failing indicator vetoes release, guaranteeing safety and efficacy.

Exosome Production Whole-Process | The “Birth Journey” of an Exosome

From umbilical cord to lyophilized powder — step by step

Step 1
Qualified donated umbilical cord

Qualified donated umbilical cord

Step 2
Isolate mesenchymal stem cells

Isolate mesenchymal stem cells

Step 3
Third-party authoritative testing (qualified)

Third-party authoritative testing (qualified)

Step 4
Establish standard cell bank

Establish standard cell bank

Step 5
Stem cell culture

Stem cell culture

Step 6
Harvest exosome supernatant

Harvest exosome supernatant

Step 7
Dual purification (exosome stock solution)

Dual purification (exosome stock solution)

Step 8
Sterile dilution & filling

Sterile dilution & filling

Step 9
Exosome lyophilization

Exosome lyophilization

Every step is clear and controllable — fully traceable from source to finished product.

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