4.1.1 CAR-T manufacturing begins with apheresis of the immune cells from peripheral blood. In the currently approved therapies, ether CD4+, CD8+, or a mixture of both types are isolated from the patient’s bloodstream. In some cases, the CD4+ and CD8+ cells are purified separately and then mixed in specific ratios in vitro. Isolation is typically performed by using magnetic beads coated with an appropriate ligand to isolate the desired cell types.[105]
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4.2.1 CAR-T doses of approved products are typically about 106 cells per kg of body weight, up to 108 cells total. To accomplish this, cells are typically filled to a specific concentration and volume. For example, Yescarta and Tecartus are both filled in 68 mL IV bags, from which they are thawed and delivered to the patient over 1–3 days. When the required dose is large, several bags may be used for one treatment.
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4.3.1 Developers of mesenchymal stem cell (MSC) therapies must determine first if they plan to create an allogeneic or autologous therapy. This choice will determine the selection criteria for the donor(s) and the types of cells that are isolated in the first step of an MSC manufacturing process. MSCs are most frequently isolated from adipose tissue, bone marrow, and cord blood, but other sources have been explored. Bone marrow–sourced MSCs have proven useful in the clinic, but harvest of bone marrow tissue is invasive and must be performed with local anesthetic. Subcutaneous adipose tissue is much easier to harvest, and is often available as a waste product from surgery.[112]
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4.4.1 Although most types of cells release nanosized vesicles, MSC-derived extracellular vesicles (EVs), or exosomes, are being explored as a therapeutic for a diverse array of indications, including acute kidney injury, spinal cord injury, and hearing loss. Because exosomes are much smaller than the parent cell, they can travel into tumors and cross the blood–brain barrier, which expands their potential indications.[112]
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4.5.1 Formulation and freezing MSCs is a similar challenge as the same steps with CAR-T therapeutics. If the indication and the cell type allow for growth after the thaw, however, a short cell culture before injection can allow for formulation with higher concentrations of DMSO. This is a trade-off, however, because it necessitates that the treatment center must either have capability to aseptically culture the cells, or close access to a facility.[112]
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4.6.1 As with MSC therapeutics, the decision to create either an allogeneic or an autologous cell therapy influences how the donor and cell type is chosen. Because the manufacturing duration can extend to several months, autologous cell therapies are currently limited to chronic conditions such as diabetes and neurological disorders.[118]
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