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What is Cell Therapy Manufacturing

January 23, 2022

Cell therapy manufacturing is the process of creating therapeutic products using living cells, tissues, or organs to treat a variety of diseases and medical conditions. It involves the isolation, culturing, and expansion of cells from a patient’s own body, from a donor, or a cell bank, followed by their processing and delivery back into the patient.

The manufacturing process begins with the selection of the appropriate cell source and the collection of the cells from the donor or the patient. The cells are then isolated and purified to obtain a homogeneous population of cells that are suitable for therapy.

Next, the cells are cultured and expanded in vitro to increase their number and to ensure that they retain their therapeutic properties. The expansion process may involve the use of growth factors, cytokines, and other substances that promote cell growth and differentiation.

Once the cells have been expanded to the desired number, they are harvested and processed to remove any contaminants or unwanted substances. The processed cells are then formulated into a therapeutic product that is ready for administration to the patient.

The therapeutic product is tested for Identity, safety, purity, potency, and stability, and is packaged and stored until it is ready for use. The manufacturing process is highly regulated and must comply with strict quality control standards to ensure the safety and efficacy of the final product.

Learn more about Center for Breakthrough Medicines cell therapy manufacturing capabilities:

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