The goal of every cell processing facility must be the production of safe, pure, and potent cells.

• Processing cellular based therapies under cGMP requires sound scientific methods which are current, validated, and documented. 

• The manipulation of cells, even in seemingly non-complex processes requires facilities, environments and methods that prevent the introduction, transmission and spread of communicable disease. TotipotentSC has the experience to guide you with this regulatory requirement.

TotipotentSC is compliance focused with patient safety serving as the base for all recommendations.  We have experience optimizing, implementing, and validating leading stem cell harvest, cell processing/expansion, environmental control, and cryopreservation technologies to ensure that you reach your purity and stability goals required under cGMP/cGTP regulations.