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QUALITY REPORT

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.

Umbilical Chord (UC)-MSC from Regenerelle 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.

Regenerelle documents the batch-to-batch consistency and reproducibility of the cells.

MORPHOLOGY:

CELL VIABILITY:

STERILE TESTING:

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

VIRUS TESTING:

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

SPECIFIC STAINING:

Positive* for CD29, CD44, CD73, CD90, CD105, CD166.

Negative* for CD14, CD31, CD34, CD45.