Commercializing cell therapies can be much more challenging than commercializing traditional pharmaceuticals and biologics. Cell-based drug products are significantly more complex than protein or small-molecule drug products. Their mechanisms of action and product attributes are also more complex. Cell therapy product attributes rely heavily on the associated manufacturing processes. Process changes can influence products in ways that may not be discernible until their effects on efficacy effects become evident. Product characterization is critical, but cell therapy products are living organisms…