2. Freeze!Four things to consider when cryopreserving a stem cell therapy.

Smart Cell Therapy

© Copyright 2011 Parenteau BioConsultants, LLC

Numbers Count

Cryopreserving for cell therapy isn’t the same as cryopreserving CHO cells for a biotech process

Viability impacts yourCost of GoodsPotencySafety

1

Your standards should be high

The stem cell therapy is a population of cells and that population defines your therapy

Is your cryopreservation process adequately preserving the population?

Cells with low viability upon thaw will raise questions as to what the thawed population really represents

2

Consistency will be key

You will be asked by regulators to define an acceptable range of viability

You may want to consider plating or colony forming efficiency checks during development to be confident the parameters you set work for your process. You’ll also then have the evidence to prove acceptable ranges when asked to justify your parameters

3

Viability Counts for the Patient

Dead cells impact your final product’s potency in two ways: Dosing

Be sure that storage, shipping and thawing is well controlled. You will ultimately need to validate that control.

If the dose is 1 X 107, 90% viable, then be sure your end process can deliver it wherever the thaw is done. If you thaw at a central facility, then ability to ship, and viability at point of use will still be yours to validate.

Inflammatory ResponseDead cells not only reduce the number of beneficially active cells in your therapy, they can

also illicit a natural inflammatory response that could work against your viable cells. A significant number of dead cells can raise safety questions.

4

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