Certificate of Analysis
Human Umbilical Cord blood Plasma Exosome (Highly Purified) – Frozen (iEXOSOMES)
(Highly Purified Exosome)-2773
Human cord blood Plasma Exosome (Highly Purified) is a cell-free product. This product
was collected aseptically from Umbilical Cord blood Plasma (UCB-PRP). UCB-PRP was
collected from Umbilical Cord blood, and Umbilical Cord blood collected at the time of
delivery from healthy pregnant women in CPD anticoagulant in a sterile collection bag.
Human Cord blood Plasma Exosome harvested in a certified class 100 cleanroom under
aseptic and good manufacture practices. Human Cord blood Plasma Exosome allografts
were obtained by sterile technique from a pre-screened donor. Rich source of mRNA,
miRNA and Proteins. Albumin and IgGs (unwanted proteins) removed from the sample.
Freshly collected Umbilical Cord Blood Plasma (UCB-PRP)
It is recommended that the Exosome store at -80 oc freezer– Away from light.
-65 oC to -80 oC , Away from light
Each lot of Umbilical Cord Blood Plasma purified Exosome are uncultured, Xeno-free,
Serum-free and tested. Each Lot of StemL X-Plus is from single donor. Umbilical Cord
Blood Plasma Purified Exosome products are stored in DPBS (Saline with no Magnesium
and no Calcium). Umbilical Cord Blood Plasma Purified Exosome products analyzed via
Nano Sight analyzer.
This material should be handled following biosafety level 2 procedures. Universal
precautions should be utilized when working with these products. Use aseptic techniques
when handling the material.
Use vials within 24 hours of receipt or store in -80 oC freezer.
Thawing the Exosome:
Recommended-Leave the vial in the refrigerator (2 oC -8 oC) until it’s completely defrosted.
The following donor screening tests have been performed:
Infectious Disease Panel:
Hepatitis B Core Antibody (Anti-HBc EIA)
Hepatitis B Surface Antigen (HBsAg EIA)
Hepatitis C Virus Antibody (Anti-HCV EIA)
Human Immunodeficiency Virus Antibody (HIV 1/2 plus O)
Human T-Lymphotropic Virus Antibody (HTLV-I/II)
HIV-1/HCV/HBV Nucleic Acid Testing
Nucleic Acid Testing
Chagas Disease (Trypanasoma cruzi) Antibody
Lyme Disease (B.burgdorferi) abs, Total ElISA, with Reflex to Western Blot
Cytomegalovirus Abs, IgG and IgM
Microbial/Fungal-Sterility Testing Results: On-File. Screening tests performed.
Donor Serology /Disease Testing Panel Results: On-File-Screening tests performed.
(For Homologous USE ONLY, THERAPEUTIC USE.)