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Cell therapy products can be modified by treatment with DNA or another nucleic acid so that the pattern of gene expression is changed.This new product, a combination of gene therapy and cell therapy, is referred to as an ex vivo gene therapy product.Qualification and sourcing of all raw materials is critical to producing a safe and effective product.Third, storage of the cell therapy products may present a challenge.Cell lines are preferable to freshly isolated cells because they can be tested extensively for viruses, tumorigenicity, and other features.They also ensure a constant and reproducible product by minimizing donor-to-donor variability.

Gene therapy products are products in which nucleic acids are used to modify the genetic material of cells.Fourth, there is often an urgent clinical need to administer a product as soon as possible.Fifth, some products consist of a batch size equivalent to one dose, very often in a small volume.Xenogeneic cells are used when human cells with the desired characteristics are not available or the supply of human donors is too limited.Cell therapy products are sometimes encapsulated in a device that prevents the patient's cells and antibodies from killing the xenogeneic cells.

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