Sample Document
Certificate of Analysis
Below is a sample Certificate of Analysis for OmniGenix Luxir+ demonstrating our commitment to full transparency and rigorous quality testing on every lot we release.
Certificate of Analysis
Growth Factor Composite for Cosmetic Use
| Product Name | Lot No. | Serial Number (S/N) | Volume (mL) | EAU | Expiration Date |
|---|---|---|---|---|---|
| OmniGenix Luxir+ | 4000053-L | X-1-04-20250109-053-L | 1 mL | 14 EAU | 2027-01 |
01 Infectious Screening of the Placental Tissue Donor
| Test Name | Proposed Acceptance Criteria | Results |
|---|---|---|
| USP<1113> Microbial Characterization, Identification, and Strain Typing | No Growth, Day 7 | Conforms |
| CMV | Negative | Conforms |
| Hepatitis B Core Total Ab | Non-Reactive | Conforms |
| Hepatitis B Surface Ag | Non-Reactive | Conforms |
| Hepatitis C Virus Ab | Non-Reactive | Conforms |
| HIV-1/HIV-2 Plus O | Non-Reactive | Conforms |
| HTLV I/II Ab | Non-Reactive | Conforms |
| Syphilis Screening - Nontreponemal | Non-Reactive | Conforms |
| Ultrio Elite HBV | Non-Reactive | Conforms |
| Ultrio Elite HCV | Non-Reactive | Conforms |
| Ultrio Elite HIV-1/2 | Non-Reactive | Conforms |
| WNV | Non-Reactive | Conforms |
| Sexually Transmitted Diseases (STD) | No Risk | Conforms |
| Ebola Virus | No Risk | Conforms |
| Malaria | No Risk | Conforms |
| Zika Virus | No Risk | Conforms |
| Chagas Disease | No Risk | Conforms |
| Creutzfeldt-Jakob Disease (CJD) | No Risk | Conforms |
Page 2 of 3
02 Master Cell Bank Safety Characterization
| Test Name | Proposed Acceptance Criteria | Results |
|---|---|---|
| Sterility Test by Membrane Filtration | No visible growth of microorganisms occurred | Conforms |
| Mycoplasma Analysis | Not Detected | Conforms |
| in vitro Adventitious Agent - MRC-5 | Not Detected | Conforms |
| in vitro Adventitious Agent - Vero | Not detected | Conforms |
| in vitro Adventitious Agent - HeLa | Not detected | Conforms |
| in vivo Inapparent Viruses | Not detected | Conforms |
| Bovine 9CFR | Not detected | Conforms |
| Porcine 9CFR | Not detected | Conforms |
| Detection of Hepatitis A Virus | Not detected | Conforms |
| Detection of Hepatitis B Virus with Interference | Not detected | Conforms |
| Detection of Hepatitis C Virus | Not detected | Conforms |
| Detection of Human T-Cell Lymphotropic Virus Type I and II with Interference | Not detected | Conforms |
| Detection of Human Immunodeficiency Virus Type 1 | Not detected | Conforms |
| Detection of Human Immunodeficiency Virus Type 2 | Not detected | Conforms |
| Detection of Human Cytomegalovirus | Not detected | Conforms |
| Detection of Human Herpesvirus Type 6 | Not detected | Conforms |
| Detection of Human Herpesvirus Type 7 | Not detected | Conforms |
| Detection of Human Herpesvirus Type 8 | Not detected | Conforms |
| Detection of Parvovirus B19 | Not detected | Conforms |
| Papillomavirus Type 16 | Not detected | Conforms |
| Papillomavirus Type 18 | Not detected | Conforms |
Page 3 of 3
03 Final Vialed Product
| Test Name | Proposed Acceptance Criteria | Results |
|---|---|---|
| Zika Virus | Not Detected | Conforms |
| JC Virus | Not Detected | Conforms |
| Covid 19 (SARS-CoV-2) | Not Detected | Conforms |
| Endotoxin Testing | <0.5 EU/mL | Conforms |
| Sterility by Direct Inoculation | No growth | Conforms |
| Mycoplasma | Negative | Conforms |
| Appearance | Clear, Colorless to Pale Yellow Solution, and Free of Foreign Particulates | Conforms |
| Exosomes Particle Size | Mode: 70–160 nm | Conforms |
| Western Blot for CD81 Biomarker | Positive | Conforms |
| SEC-HPLC | Purity No Less Than 80% | Conforms |
| Osmolality | 280–320 mOsm/kg | Conforms |
| pH | 6.5–7.5 | Conforms |
| Total Number of Particles per Vial | No Less Than 1 Trillion | Conforms |
| Normalized Total RNA Concentration | Detected | Conforms |
This product may contain traces of Penicillin, Streptomycin, Neomycin and Phenylalanine amino acid.
Prepared by
[Name]
Quality Assurance
Date: [Date]
Reviewed by
[Name]
Operations
Date: [Date]
Approved by
[Name]
Executive Leadership
Date: [Date]
OmniGenix
GMP
Certified • QA Inspected
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Contact Us
Call Us
+1 (888) 553-4777
Email Us
support@omnigenix.com
Working Hours (PST)
Monday ————- 7:00 – 5:00
Tuesday ————- 7:00 – 5:00
Wednesday ——— 7:00 – 5:00
Thursday ———— 7:00 – 5:00
Friday —————- 7:00 – 5:00
Questions?
We would be happy to answer any questions you might have about our MSC exosome products. You may call, email, or schedule a product consultation appointment at your convenience.