ISO 22716
Cosmetic GMP Compliance
Manufacturing Overview
18 Month
Total Process Duration
Class 1B
Clean room Standards
10,000
Particle Count Control
1. Class 1B Cleanroom / 10,000 Particle Count
Class 1B and 10,000 particle count mean that the air is filtered so well that it contains no more than 10,000 tiny particles per cubic foot of air about 100 times cleaner than normal room air. This level of cleanliness helps protect the quality and safety of the product, especially when dealing with something as sensitive and precise as exosomes.
2. ISO 22716 Cosmetic GMP Compliance (Global quality standard for how cosmetics are made)
ISO 22716 ensures that the product is manufactured with strict guidelines for hygiene, documentation, employee training, and safety. GMP stands for “Good Manufacturing Practices,” which basically means everything is made in a controlled, consistent and professional way.
Stem Cell Line Establishment: 3 Months
Tissue Collection
2. Donor Eligibility
3. Stem Cell Isolation
4. Culture
5. Cryogenic Freezing
Production and QC: 3 Months
1.Thaw
2. Cell Seeding
3. Condition Media Production
4. Serum-Free Conditioning
5. Media Harvest
6. Sterile Filtration
7. Quality Inspection (QC)
8. Final Product
Safety evaluation of human cell culture media from a specialized testing laboratory (BiotoxTech), following FDA guidelines from 2010. The evaluation involves 10 different safety tests, costs approximately $110,000, and will take 12 months to complete
Safety Evaluation: 12 Months
12 - Month Safety Protocol
Complete safety evaluation conducted by GLP-certified facility (Biotoxtech Co., Ltd.) following FDA guidelines (Notice No. 2010-38)
Safety Evaluation
10- Point Saftey Testing Protocol
Acute Dermal Toxicity
13-Week Repeated Toxicity
Skin Sensitization
Genotoxicity (Micronucleus)
Skir Irritation
Regression Mutation
Eye Irritation
Phototoxicity
Chromosomal Abnormality
Photosensitivity
hPL vs FBS Competitive Advantage
Key Benefits
Non-xenogeneic: Human-derived product
Animal-free: No animal serum components
Rich Growth Factors: Natural cytokines & proteins
Faster Growth: 20-30 hour population doubling
Cost-Effective: Efficient cell expansion
Safety Controlled: Rigorous pathogen testing
✓⃝ Performance Comparison
5% hPL
Equivalent to
20%FBS
[Superior long-term proliferation]
Why hPL Over FBS (Fetal Bovine Serum)?
Human Platelet Lysate demonstrates superior cell proliferation rates and safety profiles compared to traditional fetal bovine serum, making it the gold standard for xenofree cell propagation.
Key Cytokine Analysis results (hPL vs FBS):
Our Lyophilization Process
Preserving Exosome Integrity Through Precision Freeze-Drying
Precision Temperature Control
Three-Step Process
1. Initial freezing at -40°C creates optimalice crystal formation
2. Sequential temperature steps duringdrying prevent thermal shock
3.Gradual approach preserves both physical structure and biological activity
What is Lyophilization?
A freeze-drying process that removes water from exosomes while preserving their structure and biological activity. It creates a "suspended animation" state that maintains bioactive potency throughout the product's lifespan.
Mannitol Protection
Cryoprotectant Function
Mannitol acts as a molecular cushion that prevents delicate lipid membranes from breaking apart during freezing and drying.
Critical Protection
Without this protection, freeze-drying woulddestroy exosome functionality. Therefore,mannitol is absolutely essential for maintaining exosome efficacy.
Not All Lyophilization is Created Equal
Inferior Methods: Basic freeze-drying without proper cryoprotectants or temperature control can damage exosome membranes and reduce efficacy greatly.
Our Advanced Process: Sophisticated three-step temperature management with mannitol protection ensures maximum preservation of biological activity.
Quality Assurance : Precision-controlled environment maintains consistent results and prevents thermal shock damage to sensitive exosome structures.
The Exotop Pro Advantage
Our sophisticated preservation method ensures that when lyophilized exosomes are reconstituted for treatment, they're as biologically active as fresh exosomes. This makes Exotop Pro a premium, stable product that delivers consistent results when properly refrigerated throughout its lifespan.
✓⃝ Safety Results
PASSED: 9 out of 10 safety tests
Classification: Hypoallergenic sample for primary irritation
Certification: GLP test certification by Biotoxtech Co., Ltd.)
Safety & Quality Overview
✓⃝ Human Patch Test Results
CONFIRMED: Human skin safety
Classification: Non-irritating to human skin
Methodology: Clinical patch testing protocol
4-Week Human Clinical Trial
IRB Approval Number: KDRI-IRB-20879 | 13 Research Subjects
Clinical Efficacy Results
Skin Moisture
+20.35%
Increased moisture content after 4 weeks
Skin Elasticity
+15.12%
Improved Elasticity Measurement
Anti-Wrinkle
-7.91%
Wrinkle Depth Reduction
Skin Density
+32.04%
Significant density improvement
Skin Tone
+6.94%
Reduction in hyperpigmentation
Statistical Significance
All measurements showed statistically significant differences compared to control groups, confirming the anti-aging efficacy of ASC-CM in improving skin elasticity, pigmentation, and density.
Summary & Conclusion
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High-Yield Production
Secured high-yield and high-purity adipose stromal cell conditioned media through optimized manufacturing processes and hPL-based culture systems.
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Saftey Validated
Comprehensive safety proven through both animal toxicity evaluation tests and human skin patch testing protocols.
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Clinical Efficacy
Anti-aging functions demonstrated through human application testing with statistically significant improvements across multiple skin parameters
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Quality Assurance
ISO-certified manufacturing with rigorous quality control systems ensuring consistent, safe, and effective exosome rich conditioned medias.
Competitive Advantages
Human-derived: Eliminates xenogeneic risks
Superior cytokine profile: Enhanced growth factors vs. FBS
Comprehensive testing: 18-month validation process
Clinically proven: Measurable anti-aging benefits
GMP compliance: International quality standards
★ From donor screening through final product delivery, our Korean facility offers end-to-end exosome production with proven safety, efficacy, and regulatory compliance.
Exosome-rich ASC-CM represents the next generation of cosmetic active ingredients with proven safety and efficacy profiles.