Exoqure - Biomanufacturing towards innovative regenerative health solutions.

Quality Report

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Quality testing is pertinent to having a product that is effective, safe, and uncompromised throughout manufacturing. This section describes specifically the testing results of pathogen gauging prior to shipping and after low passage expansion in our lab. Additionally the specifications are listed for a variety of trait variables in the lower half of this page. Our CLIA lab partner can test final cells and grade RUO or GMP upon customer request.

NOTE: Research shows that UC-MSCs are superior to bone marrow stem cells in terms of risks of rejection, contamination, and infection. They also outperform bone marrow in their ability to replace damaged cells and have a lower risk of graft-vs-host disease (GVHD) due to their immunoprivileged characteristics.


ExoQure MSCs undergo stringent quality testing at every step of the process of isolation, expansion and cryostorage

Initial Pathogen Testing is performed on umbilical cords by a third party prior to shipping to our Medical storage facility at our Lab.

Initial Pathogen Testing
CMV total Ab Negative/Non-reactive Negative
Hepatitis B Core Total Ab Negative/Non-reactive Non-Reactive
Hepatitis B Surface Ag Negative/Non-reactive Non-Reactive
Hepatitis C Virus Ab Negative/Non-reactive Non-Reactive
HIV-1/HIV-2 Plus O Negative/Non-reactive Non-Reactive
HTLV I/II Ab Negative/Non-reactive Non-Reactive
Syphilis Screening - Nontreponemal Negative/Non-reactive Non-Reactive
Ultrio Elite HBV Negative/Non-reactive Non-Reactive
Ultrio Elite HCV Negative/Non-reactive Non-Reactive
Ultrio Elite HIV-1/2 Negative/Non-reactive Non-Reactive
WNV Negative/Non-reactive Non-Reactive

Following low passage expansion of MSCs, product quality tested by a 3rd party certified CLIA lab to confirm viability, identity and safety of the batch.

Confirmation of Identity
Post thaw viability ≥ 90% by trypan blue test 94%
MSC phenotype (CD73+ CD90+ CD105+) ≥ 95% Positive 0.962
Non-MSC phenotype (CD11b, CD14, CD19, CD34, CD45, CD79, HLA-DR) ≤ 2% 0.0053
Advanced Therapies Testing
Endotoxin < 0.5 EU/mL
Sterility Negative Negative
HCV Negative Negative
HTLV Type I/II Negative Negative
Treponema pallidum CAPTIA Negative Negative
Mycoplasma Negative Negative

Batch-to-batch consistency and reproducibility of the cells

Umbilical Chord (UC)-MSC from ExoQure are characterized by immunofluorescence with antibodies specific to CD73, CD90 and CD105. UC-MSC are negative for HIV-1, HBV, HCV, mycoplasma, bacteria, yeast and fungi.


Normal morphology for low passages


Minimum % 85 viability when thawed from cryopreservation (our competitors are 70%)


Negative for mycoplasma. Negative for bacterial and fungal growth


Negative for HIV-1, HIV-2, HBV, and HCV by PCR


Positive* for CD29, CD44, CD73, CD90, CD105, CD166. Negative* for CD14, CD31, CD34, CD45.