Can you explain the difference between autologous and allogeneic stem cell therapies in terms of how they are manufactured clinically.

Answer

All stem cell therapies should be manufactured under Good Manufacturing Practices (GMPs). The primary difference between allogeneic and autologous are the source of the cells for the therapy. Allogeneic therapies are manufactured in large batches from unrelated donor tissues (such as bone marrow) whereas autologous therapies are manufactured as a single lot from the patient being treated. For some autologous therapies, the cells from the patient are processed on site at the clinic or hospital. These therapies are not regulated as a biologic product and not produced under GMP but rather the devices used are regulated.

While both therapies use similar technologies common to the growth of cells, the scale is different. Allogeneic therapies are “off the shelf”, used to treat many patients (sometimes thousands) and more time is available to quality control the product prior to administration. Autologous therapies are “custom” products for each patient and the chain of identity of the patient samples is critical to assure the right product is returned to the patient. Scale up of manufacturing for allogeneic cells is similar to techniques used to make protein drugs and other large scale cell derived materials while autologous cells require scale out, the production of many individual products at the same time.