Exoqure - Biomanufacturing towards innovative regenerative health solutions.

QUALITY STANDARD:

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

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.