The client had developed an ex vivo expansion strategy requiring the use of fetal bovine serum (FBS) and a multi-cytokine cocktail to optimize expansion of the target cells. In a pre-IND meeting, the FDA advised the client that a final wash procedure with demonstrated clearance of residual cytokines and FBS was required to allow release of final product for administration to patients.
The client did not have the internal expertise or equipment to define, develop and qualify suitable assay test methods. However, PCT was able to help the client set up and execute the processes needed to enable compliance with the FDA's guidelines for final distribution to patients—at a fraction of the cost of doing so internally!
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